Oncology (Cancer)/Hematologic Malignancies Approval Notifications
FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.
| Webpage | Description | Date |
|---|---|---|
| FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer | On October 3, 2024, the Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. | 10/3/2024 |
| FDA approves selpercatinib for medullary thyroid cancer with a RET mutation | On September 27, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy. | 9/27/2024 |
| FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy | On September 25, 2024, the Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | 9/25/2024 |
| FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma | On September 20, 2024, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, Sanofi-Aventis U.S. LLC) with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). | 9/20/2024 |
| FDA approves amivantamab-vmjw with carboplatin and pemetrexed for non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations | On September 19, 2024, the Food and Drug Administration approved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor. | 9/19/2024 |
| FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma | On September 17, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM). | 9/17/2024 |
| FDA approves Kisqali with an aromatase inhibitor and Kisqali Femara Co-Pack for early high-risk breast cancer | On September 17, 2024, the Food and Drug Administration approved ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. Additionally, FDA also approved the ribociclib and letrozole co-pack (Kisqali Femara Co-Pack, Novartis Pharmaceuticals Corporation) for the same indication. | 9/17/2024 |
| FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection | On September 12, 2024, the Food and Drug Administration approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq, Genentech, Inc.), including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS). See the prescribing information for the specific indications. | 9/12/2024 |
| FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer | On August 19, 2024, the Food and Drug Administration approved lazertinib (Lazcluze, Janssen Biotech, Inc.) in combination with amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. | 8/19/2024 |
| FDA approves neoadjuvant/adjuvant durvalumab for resectable non-small cell lung cancer | On August 15, 2024, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. | 8/15/2024 |
| FDA approves axatilimab-csfr for chronic graft-versus-host disease | On August 14, 2024, the Food and Drug Administration approved axatilimab-csfr (Niktimvo, Incyte Corporation), a colony stimulating factor-1 receptor-blocking antibody, for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. | 8/14/2024 |
| FDA approves vorasidenib for Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation | On August 6, 2024, the Food and Drug Administration approved vorasidenib (Voranigo, Servier Pharmaceuticals LLC), an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, for adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, following surgery including biopsy, sub-total resection, or gross total resection. | 8/6/2024 |
| FDA grants accelerated approval to afamitresgene autoleucel for unresectable or metastatic synovial sarcoma | On August 2, 2024, the Food and Drug Administration granted accelerated approval to afamitresgene autoleucel (TECELRA, Adaptimmune, LLC), a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy, for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. | 8/2/2024 |
| FDA expands endometrial cancer indication for dostarlimab-gxly with chemotherapy | On August 1, 2024, the Food and Drug Administration approved dostarlimab-gxly (Jemperli, GSK) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for adult patients with primary advanced or recurrent endometrial cancer (EC). | 8/1/2024 |
| FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for multiple myeloma | On July 30, 2024, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Research & Development, LLC) in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). | 7/30/2024 |
| FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma | On June 26, 2024, the Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US, Inc.), a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. | 6/26/2024 |
| FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C-mutated colorectal cancer | On June 21, 2024, the Food and Drug Administration granted accelerated approval to adagrasib (Krazati; Mirati Therapeutics, Inc.) plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. | 6/21/2024 |
| FDA approves pembrolizumab with chemotherapy for primary advanced or recurrent endometrial carcinoma | On June 17, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma. | 6/17/2024 |
| FDA approves blinatumomab as consolidation for CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia | On June 14, 2024, the Food and Drug Administration approved blinatumomab (Blincyto, Amgen Inc.) for adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (Ph-negative BCP ALL) in the consolidation phase of multiphase chemotherapy. | 6/14/2024 |
| FDA approves durvalumab with chemotherapy for mismatch repair deficient primary advanced or recurrent endometrial cancer | On June 14, 2024, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca UK Limited) with carboplatin plus paclitaxel followed by single-agent durvalumab for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). | 6/14/2024 |
| On June 13, 2024, the Food and Drug Administration granted accelerated approval to repotrectinib (AUGTYRO, Bristol-Myers Squibb Company) for adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy. | 6/13/2024 | |
| FDA approves selpercatinib for RET fusion-positive thyroid cancer | On June 12, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). | 6/12/2024 |
| FDA approves imetelstat for low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia | On June 6, 2024, the Food and Drug Administration approved imetelstat (Rytelo, Geron Corporation), an oligonucleotide telomerase inhibitor, for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). | 6/6/2024 |
| FDA approves lisocabtagene maraleucel for relapsed or refractory mantle cell lymphoma | On May 30, 2024, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor (BTKi). | 5/30/2024 |
| FDA grants accelerated approval to selpercatinib for pediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumors | On May 29, 2024, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two years of age and older. | 5/29/2024 |
| FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer | On May 16, 2024, the Food and Drug Administration granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. | 5/16/2024 |
| FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma | On May 15, 2024, the Food and Drug Administration granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. | 5/15/2024 |
| FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer | On April 29, 2024, the Food and Drug Administration granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc. [now a part of Pfizer Inc.]) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin-tftv previously received accelerated approval for this indication. | 4/29/2024 |
| FDA grants accelerated approval to tovorafenib for patients with relapsed or refractory BRAF-altered pediatric low-grade glioma | On April 23, 2024, the Food and Drug Administration granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. | 4/23/2024 |
| FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETS | On April 23, 2024, the Food and Drug Administration approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company) for pediatric patients 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. Lutetium Lu 177 dotatate received approval for this indication for adults in 2018. | 4/23/2024 |
| FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer | On April 22, 2024, the Food and Drug Administration approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. | 4/22/2024 |
| FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer | On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. | 4/18/2024 |
| FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors | On April 5, 2024, the Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. | 4/5/2024 |
| FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer | On March 22, 2024, the Food and Drug Administration approved mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc. [now a part of AbbVie]) for adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Patients are selected based on an FDA-approved test. | 3/22/2024 |
| FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products | On March 21, 2024, the Food and Drug Administration approved safety labeling changes for fluorouracil injection products. This effort was a collaboration between FDA’s Office of Generic Drugs and the Oncology Center of Excellence (OCE). | 3/21/2024 |
| FDA grants accelerated approval to ponatinib with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia | On March 19, 2024, the Food and Drug Administration granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals U.S.A., Inc.) with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). | 3/19/2024 |
| FDA grants accelerated approval to zanubrutinib for relapsed or refractory follicular lymphoma | On March 7, 2024, the Food and Drug Administration granted accelerated approval to zanubrutinib (Brukinsa, BeiGene USA, Inc.) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. | 3/7/2024 |
| FDA approves nivolumab in combination with cisplatin and gemcitabine for unresectable or metastatic urothelial carcinoma | On March 6, 2024, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC). | 3/7/2024 |
| FDA approves inotuzumab ozogamicin for pediatric patients with acute lymphoblastic leukemia | On March 6, 2024, the Food and Drug Administration approved inotuzumab ozogamicin (Besponsa, Pfizer) for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). | 3/6/2024 |
| FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications | On March 1, 2024, the Food and Drug Administration approved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test. | 3/1/2024 |
| FDA approves osimertinib with chemotherapy for EGFR-mutated non-small cell lung cancer | On February 16, 2024, the Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | 2/16/2024 |
| FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma | On February 16, 2024, the Food and Drug Administration granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.), a tumor-derived autologous T cell immunotherapy, for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor. | 2/16/2024 |
| FDA approves tepotinib for metastatic non-small cell lung cancer | On February 15, 2024, the Food and Drug Administration granted traditional approval to tepotinib (Tepmetko, EMD Serono, Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. | 2/15/2024 |
| FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma | On February 13, 2024, the Food and Drug Administration approved irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, Inc.) with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma. | 2/13/2024 |
| FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma | On January 19, 2024, the Food and Drug Administration approved erdafitinib (Balversa, Janssen Biotech) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. Erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This approval amends the indication previously granted under accelerated approval for patients with mUC with susceptible FGFR3 or FGFR2 alterations after prior platinum-containing chemotherapy. | 1/18/2024 |
| FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 Stage III-IVA cervical cancer | On January 12, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with chemoradiotherapy (CRT) for patients with FIGO 2014 Stage III-IVA cervical cancer. | 1/12/2024 |
| FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer | On December 15, 2023, the Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma) in combination with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial cancer (la/mUC). FDA previously granted accelerated approval to this combination for patients with la/mUC who are ineligible for cisplatin-containing chemotherapy. | 12/15/2023 |
| FDA approves belzutifan for advanced renal cell carcinoma | On December 14, 2023, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). | 12/14/2023 |
| FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma | On December 13, 2023, the Food and Drug Administration approved eflornithine (IWILFIN, USWM, LLC) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. | 12/13/2023 |
| FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma | On December 1, 2023, the Food and Drug Administration granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. | 12/1/2023 |
| FDA approves nirogacestat for desmoid tumors | On November 27, 2023, the Food and Drug Administration approved nirogacestat (OGSIVEO, SpringWorks Therapeutics, Inc.) for adult patients with progressing desmoid tumors who require systemic treatment. This is the first approved treatment for desmoid tumors. | 11/27/2023 |
| FDA approves enzalutamide for non-metastatic castration-sensitive prostate cancer with biochemical recurrence | On November 16, 2023, the Food and Drug Administration approved enzalutamide (Xtandi, Astellas Pharma US, Inc.) for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). | 11/17/2023 |
| FDA approves capivasertib with fulvestrant for breast cancer | On November 16, 2023, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca Pharmaceuticals) with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. | 11/16/2023 |
| FDA approves pembrolizumab with chemotherapy for HER2-negative gastric or gastroesophageal junction adenocarcinoma | On November 16, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. | 11/16/2023 |
| FDA approves repotrectinib for ROS1-positive non-small cell lung cancer | On November 15, 2023, the Food and Drug Administration approved repotrectinib (Augtyro, Bristol-Myers Squibb Company) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). | 11/15/2023 |
| FDA approves fruquintinib in refractory metastatic colorectal cancer | On November 8, 2023, the Food and Drug Administration approved fruquintinib (Fruzaqla, Takeda Pharmaceuticals, Inc.) for adult patients with metastatic colorectal cancer (mCRC) who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. | 11/8/2023 |
| FDA amends pembrolizumab’s gastric cancer indication | On November 7, 2023, the Food and Drug Administration revised the existing indication of pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This updated indication, which remains approved under accelerated approval regulations, restricts its use to patients whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-approved test. | 11/7/2023 |
| FDA approves pembrolizumab with chemotherapy for biliary tract cancer | On October 31, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) to be used with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer (BTC). | 10/31/2023 |
| FDA approves toripalimab-tpzi for nasopharyngeal carcinoma | On October 27, 2023, the Food and Drug Administration approved toripalimab-tpzi (LOQTORZ, Coherus BioSciences, Inc.) with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. | 10/27/2023 |
| FDA approves ivosidenib for myelodysplastic syndromes | On October 24, 2023, the Food and Drug Administration approved ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test. | 10/24/2023 |
| FDA expands pediatric indication for entrectinib and approves new pellet formulation | On October 20, 2023, the Food and Drug Administration granted accelerated approval to entrectinib (Rozlytrek, Genentech Inc.) for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. In August 2019, FDA granted accelerated approval to entrectinib for pediatric patients 12 years of age and older for this indication. | 10/20/2023 |
| FDA approves neoadjuvant/ adjuvant pembrolizumab for resectable non-small cell lung cancer | On October 16, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). | 10/16/2023 |
| FDA approves nivolumab for adjuvant treatment of Stage IIB/C melanoma | On October 13, 2023, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for the adjuvant treatment of completely resected Stage IIB/C melanoma in patients 12 years and older. | 10/13/2023 |
| FDA approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutation | On October 11, 2023, the Food and Drug Administration approved encorafenib (Braftovi, Array BioPharma Inc., a wholly owned subsidiary of Pfizer) with binimetinib (Mektovi, Array BioPharma Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. | 10/11/2023 |
| FDA approves bosutinib for pediatric patients with chronic myelogenous leukemia | On September 26, 2023, the Food and Drug Administration approved bosutinib (Bosulif, Pfizer) for pediatric patients 1 year of age and older with chronic phase (CP) Ph+ chronic myelogenous leukemia (CML) that is newly diagnosed (ND) or resistant or intolerant (R/I) to prior therapy. The FDA also approved a new capsule dosage form available in strengths of 50 mg and 100 mg. | 9/26/2023 |
| FDA approves new and updated indications for temozolomide under Project Renewal | On September 14, 2023, the Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. This is the second drug to receive a labeling update under this pilot program. The first drug that received approval under Project Renewal was capecitabine (Xeloda). | 9/14/2023 |
| FDA approves melphalan as a liver-directed treatment for uveal melanoma | On August 14, 2023, the Food and Drug Administration approved HEPZATO KIT (melphalan for Injection/Hepatic Delivery System) containing melphalan (HEPZATO, Delcath Systems, Inc.) as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. | 8/14/2023 |
| FDA grants accelerated approval to elranatamab-bcmm for multiple myeloma | On August 14, 2023, the Food and Drug Administration granted accelerated approval to elranatamab-bcmm (Elrexfio, Pfizer, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. | 8/14/2023 |
| FDA approves niraparib and abiraterone acetate plus prednisone for BRCA-mutated metastatic castration-resistant prostate cancer | On August 11, 2023, the Food and Drug Administration approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.), with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test. | 8/11/2023 |
| FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma | On August 9, 2023, the Food and Drug Administration granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech, Inc.) adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. | 8/9/2023 |
| FDA approves pralsetinib for non-small cell lung cancer with RET gene fusions | On August 9, 2023, the Food and Drug Administration granted regular approval to pralsetinib (Gavreto, Genentech, Inc.) for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. | 8/9/2023 |
| FDA approves trifluridine and tipiracil with bevacizumab for previously treated metastatic colorectal cancer | On August 2, 2023, the Food and Drug Administration approved trifluridine and tipiracil (LONSURF, Taiho Oncology, Inc.) with bevacizumab, for metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. FDA had previously approved single-agent LONSURF for this indication in September 2015. | 8/2/2023 |
| FDA approves dostarlimab-gxly with chemotherapy for endometrial cancer | On July 31, 2023, the Food and Drug Administration approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer (EC) that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H). | 7/31/2023 |
| FDA approves quizartinib for newly diagnosed acute myeloid leukemia | On July 20, 2023, the Food and Drug Administration approved quizartinib (Vanflyta, Daiichi Sankyo, Inc.) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test. | 7/20/2023 |
| FDA approves talazoparib with enzalutamide for HRR gene-mutated metastatic castration-resistant prostate cancer | On June 20, 2023, the Food and Drug Administration approved talazoparib (Talzenna, Pfizer, Inc.) with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). | 6/20/2023 |
| FDA grants accelerated approval to glofitamab-gxbm for selected relapsed or refractory large B-cell lymphomas | On June 15, 2023, the Food and Drug Administration granted accelerated approval to glofitamab-gxbm (Columvi, Genentech, Inc.) for relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. | 6/16/2023 |
| FDA approves olaparib with abiraterone and prednisone (or prednisolone) for BRCA-mutated metastatic castration-resistant prostate cancer | On May 31, 2023, the Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals LP) with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test. | 5/31/2023 |
| FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma | On May 19, 2023, the Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US, Inc.) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. | 5/19/2023 |
| FDA approves polatuzumab vedotin-piiq for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma | On April 19, 2023, the Food and Drug Administration approved polatuzumab vedotin-piiq (Polivy, Genentech, Inc.) with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of 2 or greater. | 4/19/2023 |
| FDA approves omidubicel to reduce time to neutrophil recovery and infection in patients with hematologic malignancies | On April 17, 2023, the Food and Drug Administration approved omidubicel-onlv (Omisirge, Gamida Cell Ltd.) for use in adult and pediatric patients (12 years and older) with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. | 4/17/2023 |
| FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinoma | On April 3, 2023, the Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev, Astellas Pharma) with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. | 4/3/2023 |
| FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma | On March 22, 2023, the Food and Drug Administration granted accelerated approval to retifanlimab-dlwr (Zynyz, Incyte Corporation) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). | 3/22/2023 |
| FDA approves dabrafenib with trametinib for pediatric patients with low-grade glioma with a BRAF V600E mutation | On March 16, 2023, the Food and Drug Administration approved dabrafenib (Tafinlar, Novartis) with trametinib (Mekinist, Novartis) for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. The FDA also approved new oral formulations of both drugs suitable for patients who cannot swallow pills. | 3/16/2023 |
| FDA expands early breast cancer indication for abemaciclib with endocrine therapy | On March 3, 2023, the Food and Drug Administration (FDA) approved abemaciclib (Verzenio, Eli Lilly and Company) with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. | 3/3/2023 |
| FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer | On February 9, 2023, the Food and Drug Administration (FDA) approved dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. | 2/9/2023 |
| FDA approves sacituzumab govitecan-hziy for HR-positive breast cancer | On February 3, 2023, the Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. | 2/3/2023 |
| FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer | On January 27, 2023, the Food and Drug Administration (FDA) approved elacestrant (Orserdu, Stemline Therapeutics, Inc.) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. | 1/27/2023 |
| FDA grants accelerated approval to pirtobrutinib for relapsed or refractory mantle cell lymphoma | On January 27, 2023, the Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. | 1/27/2023 |
| FDA approves pembrolizumab as adjuvant treatment for non-small cell lung cancer | On January 26, 2023, the Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC). | 1/26/2023 |
| FDA approves zanubrutinib for chronic lymphocytic leukemia or small lymphocytic lymphoma | On January 19, 2023, the Food and Drug Administration (FDA) approved zanubrutinib (Brukinsa, BeiGene USA, Inc.) for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). | 1/19/2023 |
| FDA grants accelerated approval to tucatinib with trastuzumab for colorectal cancer | On January 19, 2023, the Food and Drug Administration (FDA) granted accelerated approval to tucatinib (Tukysa, Seagen Inc.) in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. | 1/19/2023 |
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FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma |
On December 22, 2022, the Food and Drug Administration (FDA) granted accelerated approval to mosunetuzumab-axgb (Lunsumio, Genentech, Inc.), a bispecific CD20-directed CD3 T-cell engager for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. | 12/23/2022 |
| FDA approves first adenoviral vector-based gene therapy for high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer | On December 16, 2022, the Food and Drug Administration approved nadofaragene firadenovec-vncg (Adstiladrin, Ferring Pharmaceuticals) for adult patients with high-risk Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. | 12/16/2022 |
| FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal | On December 14, 2022, the Food and Drug Administration approved updated labeling for capecitabine tablets (Xeloda, Genentech, Inc.) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. | 12/14/2022 |
| FDA grants accelerated approval to adagrasib for KRAS G12C-mutated NSCLC | On December 12, 2022, the Food and Drug Administration (FDA) granted accelerated approval to adagrasib (Krazati, Mirati Therapeutics, Inc.), a RAS GTPase family inhibitor, for adult patients with KRAS G12C¬-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. | 12/12/2022 |
| FDA grants approval to atezolizumab for alveolar soft part sarcoma | On December 9, 2022, the Food and Drug Administration (FDA) approved atezolizumab (Tecentriq, Genentech, Inc.) for adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS). | 12/9/2022 |
| FDA approves olutasidenib for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation | On December 1, 2022, the Food and Drug Administration (FDA) approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. | 12/1/2022 |
| FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant) | On November 18, 2022, the Food and Drug Administration approved a new Monday-Wednesday-Friday dosing regimen for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze, Jazz Pharmaceuticals). Under the new regimen, patients should receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings, and 50 mg/m2 intramuscularly on Friday afternoon. It also is approved to be administered every 48 hours at a dose of 25 mg/m2 intramuscularly. | 11/18/2022 |
| FDA grants accelerated approval to mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer | On November 14, 2022, the Food and Drug Administration granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc.) for adult patients with folate receptor alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Mirvetuximab soravtansine-gynx is a folate receptor alpha directed antibody and microtubule inhibitor conjugate. Patients are selected for therapy based on an FDA-approved test. | 11/14/2022 |
| FDA approves tremelimumab in combination with durvalumab and platinum-based chemotherapy for metastatic non-small cell lung cancer | On November 10, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. | 11/10/2022 |
| FDA approves brentuximab vedotin in combination with chemotherapy for pediatric patients with classical Hodgkin lymphoma | On November 10, 2022, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen, Inc.) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma (cHL). This is the first pediatric approval for brentuximab vedotin. | 11/10/2022 |
| FDA approves cemiplimab-rwlc in combination with platinum-based chemotherapy for non-small cell lung cancer | On November 8, 2022, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations. | 11/8/2022 |
| FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma | On October 25, 2022, the Food and Drug Administration granted accelerated approval to teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. | 10/25/2022 |
| FDA approves tremelimumab in combination with durvalumab for unresectable hepatocellular carcinoma | On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (uHCC). | 10/21/2022 |
| FDA grants accelerated approval to futibatinib for cholangiocarcinoma | On September 30, 2022, the Food and Drug Administration granted accelerated approval to futibatinib (Lytgobi, Taiho Oncology, Inc.) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. | 9/30/2022 |
| FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive non-small cell lung cancer | On September 21, 2022, the Food and Drug Administration granted regular approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test. | 9/21/2022 |
| FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors | On September 21, 2022, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. | 9/21/2022 |
| FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors | On September 20, 2022, the Food and Drug Administration approved sodium thiosulfate (Pedmark, Fennec Pharmaceuticals Inc.) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumors. | 9/20/2022 |
| FDA approves durvalumab for locally advanced or metastatic biliary tract cancer | On September 2, 2022, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca UK Limited) in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer (BTC). | 9/02/2022 |
| FDA approves pemigatinib for relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement | On August 26, 2022, the Food and Drug Administration approved pemigatinib (Pemazyre, Incyte Corporation) for adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement. | 8/26/2022 |
| FDA approves ibrutinib for pediatric patients with chronic graft versus host disease, including a new oral suspension | On August 24, 2022, the Food and Drug Administration approved ibrutinib (Imbruvica, Pharmacyclics LLC) for pediatric patients ≥ 1 year of age with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension. | 8/24/2022 |
| FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer | On August 11, 2022, the Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This is the first drug approved for HER2-mutant NSCLC. | 8/11/2022 |
| FDA approves capmatinib for metastatic non-small cell lung cancer | On August 10, 2022, the Food and Drug Administration granted regular approval to capmatinib (Tabrecta, Novartis Pharmaceuticals Corp.) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test. | 8/10/2022 |
| FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer | On August 5, 2022, the Food and Drug Administration approved darolutamide (Nubeqa, Bayer HealthCare Pharmaceuticals Inc.) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). | 8/5/2022 |
| FDA approves fam-trastuzumab deruxtecan-nxki for HER2-low breast cancer | On August 5, 2022, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH‑) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. | 8/5/2022 |
| FDA approves crizotinib for ALK-positive inflammatory myofibroblastic tumor | On July 14, 2022, the Food and Drug Administration approved crizotinib (Xalkori, Pfizer Inc.) for adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT). | 7/14/2022 |
| FDA approves lisocabtagene maraleucel for second-line treatment of large B-cell lymphoma | On June 24, 2022, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adult patients with large B-cell lymphoma (LBCL) who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. It is not indicated for the treatment of patients with primary central nervous system lymphoma. | 6/24/2022 |
| FDA grants accelerated approval to dabrafenib in combination with trametinib for unresectable or metastatic solid tumors with BRAF V600E mutation | On June 22, 2022, the Food and Drug Administration granted accelerated approval to dabrafenib (Tafinlar, Novartis) in combination with trametinib (Mekinist, Novartis) for the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. | 6/22/2022 |
| FDA approves tisagenlecleucel for relapsed or refractory follicular lymphoma | On May 27, 2022, the Food and Drug Administration granted accelerated approval to tisagenlecleucel (Kymriah, Novartis Pharmaceuticals Corporation) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. | 5/27/2022 |
| FDA approves Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line esophageal squamous cell carcinoma indications |
On May 27, 2022, the Food and Drug Administration approved the following for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC):
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5/27/2022 |
| FDA approves ivosidenib in combination with azacitidine for newly diagnosed acute myeloid leukemia | On May 25, 2022, the Food and Drug Administration approved ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) in combination with azacitidine for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. | 5/25/2022 |
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FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukemia |
On May 20, 2022, the Food and Drug Administration approved azacitidine (Vidaza, Celgene Corp.) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML). |
5/20/2022 |
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FDA grants regular approval to fam-trastuzumab deruxtecan-nxki for breast cancer |
On May 4, 2022, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy. |
5/4/2022 |
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FDA approves alpelisib for PIK3CA-related overgrowth spectrum |
On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis Pharmaceuticals) for adult and pediatric patients two years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy. |
4/6/2022 |
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FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma |
On April 1, 2022, the Food and Drug Administration approved axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for the treatment of patients with primary central nervous system lymphoma. | 4/1/2022 |
| FDA approves Pluvicto for metastatic castration-resistant prostate cancer | On March 23, 2022, the Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced Accelerator Applications USA, Inc., a Novartis company) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. | 3/23/2022 |
| FDA approves pembrolizumab for advanced endometrial carcinoma | On March 21, 2022, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck), as a single agent, for patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation. | 3/21/2022 |
| FDA approves Opdualag for unresectable or metastatic melanoma | On March 18, 2022, the Food and Drug Administration approved nivolumab and relatlimab-rmbw (Opdualag, Bristol-Myers Squibb Company) for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. Opdualag is a fixed-dose combination of the LAG-3-blocking antibody relatlimab and the programmed death receptor-1 blocking antibody nivolumab | 3/18/2022 |
| FDA approves olaparib for adjuvant treatment of high-risk early breast cancer | On March 11, 2022, the Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals, LP) for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must be selected for therapy based on an FDA-approved companion diagnostic for olaparib | 3/11/2022 |
| FDA approves neoadjuvant nivolumab and platinum-doublet chemotherapy for early-stage non-small cell lung cancer | On March 4, 2022, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting. | 3/4/2022 |
| FDA approves ciltacabtagene autoleucel for relapsed or refractory multiple myeloma | On February 28, 2022, the Food and Drug Administration approved ciltacabtagene autoleucel (CARVYKTI, Janssen Biotech, Inc.) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. | 2/28/2022 |
| FDA approves tebentafusp-tebn for unresectable or metastatic uveal melanoma | On January 25, 2022, the Food and Drug Administration approved tebentafusp-tebn (Kimmtrak, Immunocore Limited), a bispecific gp100 peptide-HLA-directed CD3 T cell engager, for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. | 1/25/2022 |
| FDA approves abatacept for prophylaxis of acute graft versus host disease | On December 15, 2021, the Food and Drug Administration approved abatacept (Orencia, Bristol-Myers Squibb Company) for the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX), in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. | 12/15/2021 |
| FDA approves pembrolizumab for adjuvant treatment of Stage IIB or IIC melanoma | On December 3,2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for the adjuvant treatment of adult and pediatric (≥12 years of age) patients with stage IIB or IIC melanoma following complete resection. | 12/3/2021 |
| FDA approves rituximab plus chemotherapy for pediatric cancer indications | On December 2, 2021, the Food and Drug Administration approved rituximab (Rituxan, Genentech, Inc.) in combination with chemotherapy for pediatric patients (≥6 months to <18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL). | 12/2/2021 |
| FDA approves Darzalex Faspro, Kyprolis, and Dexamethasone for Multiple Myeloma | On November 30, 2021, the Food and Drug Administration approved daratumumab + hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) and carfilzomib (Kyprolis, Amgen, Inc.) plus dexamethasone foradult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. | 12/01/2021 |
| FDA approves pafolacianine for identifying malignant ovarian cancer lesions | On November 29, 2021, the Food and Drug Administration approved pafolacianine (Cytalux, On Target Laboratories, LLC), an optical imaging agent, for adult patients with ovarian cancer as an adjunct for interoperative identification of malignant lesions. Pafolacianine is a fluorescent drug that targets folate receptor which may be overexpressed in ovarian cancer. It is used with a Near-Infrared (NIR) fluorescence imaging system cleared by the FDA for specific use with pafolacianine. | 11/29/2021 |
| FDA approves sirolimus protein-bound particles for malignant perivascular epithelioid cell tumor | On November 22, 2021, the Food and Drug Administration approved sirolimus protein-bound particles for injectable suspension (albumin-bound) (Fyarro, Aadi Bioscience, Inc.) for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). | 11/23/2021 |
| FDA approves pembrolizumab for adjuvant treatment of renal cell carcinoma | On November 17, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. | 11/17/2021 |
| FDA approves asciminib for Philadelphia chromosome-positive chronic myeloid leukemia | On October 29, 2021, the Food and Drug Administration granted accelerated approval to asciminib (Scemblix, Novartis AG) for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs), and approved asciminib for adult patients with Ph+ CML in CP with the T315I mutation. | 10/29/2021 |
| FDA approves atezolizumab as adjuvant treatment for non-small cell lung cancer | On October 15, 2021, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test. | 10/15/2021 |
FDA approves pembrolizumab combination for the first-line treatment of cervical cancer |
On October 13, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test. | 10/13/2021 |
| FDA approves abemaciclib with endocrine therapy for early breast cancer | On October 12, 2021, the Food and Drug Administration approved abemaciclib (Verzenio, Eli Lilly and Company) with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%, as determined by an FDA approved test. This is the first CDK 4/6 inhibitor approved for adjuvant treatment of breast cancer. | 10/12/2021 |
| FDA recognizes Memorial Sloan-Kettering database of molecular tumor marker information | On October 7, 2021, the Food and Drug Administration granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OncoKB) as the first tumor mutation database to be included in the Public Human Genetic Variant Databases. | 10/7/2021 |
| On October 1, 2021, the Food and Drug Administration approved brexucabtagene autoleucel (Tecartus, Kite Pharma, Inc.) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). | 10/1/2021 | |
| FDA approves ruxolitinib for chronic graft-versus-host disease |
On September 22, 2021, the Food and Drug Administration approved ruxolitinib (Jakafi, Incyte Corp.) for chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. |
9/22/2021 |
| FDA grants accelerated approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer | On September 20, 2021, the Food and Drug Administration granted accelerated approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc.), a tissue factor-directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. | 9/20/2021 |
| FDA approves cabozantinib for differentiated thyroid cancer | On September 17, 2021, the Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis, Inc.) for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are ineligible or refractory to radioactive iodine. | 9/17/2021 |
| FDA grants accelerated approval to mobocertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations | Food and Drug Administration granted accelerated approval to mobocertinib (Exkivity, Takeda Pharmaceuticals, Inc.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. | 9/15/2021 |
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FDA grants accelerated approval to zanubrutinib for marginal zone lymphoma |
Food and Drug Administration granted accelerated approval to zanubrutinib (Brukinsa, BeiGene) for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. | 9/14/2021 |
| FDA approves zanubrutinib for Waldenström’s macroglobulinemia | Food and Drug Administration approved zanubrutinib (Brukinsa, BeiGene) for adult patients with Waldenström’s macroglobulinemia (WM). | 9/1/2021 |
| FDA approves ivosidenib for advanced or metastatic cholangiocarcinoma | Food and Drug Administration approved ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. |
8/25/2021 |
| FDA approves nivolumab for adjuvant treatment of urothelial carcinoma | Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Co.) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection. | 8/19/2021 |
| FDA grants accelerated approval to dostarlimab-gxly for dMMR advanced solid tumors | Food and Drug Administration granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. | 8/18/2021 |
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FDA approves belzutifan for cancers associated with von Hippel-Lindau disease |
Food and Drug Administration approved belzutifan (Welireg, Merck), a hypoxia-inducible factor inhibitor for adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery | 8/13/2021 |
| FDA approves lenvatinib plus pembrolizumab for advanced renal cell carcinoma | Food and Drug Administration approved the combination of lenvatinib (Lenvima, Eisai) plus pembrolizumab (Keytruda, Merck) for first-line treatment of adult patients with advanced renal cell carcinoma (RCC). | 8/10/2021 |
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FDA approves pembrolizumab for high-risk early-stage triple-negative breast cancer |
Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. | 7/26/2021 |
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FDA grants regular approval to pembrolizumab and lenvatinib for advanced endometrial carcinoma |
Food and Drug Administration approved pembrolizumab (Keytruda, Merck) in combination with lenvatinib (Lenvima, Eisai) for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. | 7/21/2021 |
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FDA approves belumosudil for chronic graft-versus-host disease |
Food and Drug Administration approved belumosudil (Rezurock, Kadmon Pharmaceuticals, LLC), a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy. | 7/16/2021 |
| FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma | Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. | 7/9/2021 |
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Food and Drug Administration approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma US, Inc.), a Nectin-4-directed antibody and microtubule inhibitor conjugate, for adult patients with locally advanced or metastatic urothelial cancer who
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7/9/2021 | |
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FDA approves asparaginase erwinia chrysanthemi (recombinant) for leukemia and lymphoma |
Food and Drug Administration approved asparaginase erwinia chrysanthemi (recombinant)-rywn) (Rylaze, Jazz Pharmaceuticals, Inc.) as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase. . | 7/1/2021 |
| FDA approves avapritinib for advanced systemic mastocytosis |
Food and Drug Administration approved avapritinib (Ayvakit™, Blueprint Medicines Corp.) for adult patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). |
6/16/2021 |
| FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma | Food and Drug Administration granted accelerated approval to infigratinib (Truseltiq, QED Therapeutics, Inc.), a kinase inhibitor for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test | 5/28/2021 |
| FDA grants accelerated approval to sotorasib for KRAS G12C mutated NSCLC | Food and Drug Administration granted accelerated approval to sotorasib (Lumakras™, Amgen, Inc.), a RAS GTPase family inhibitor, for adult patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy. | 5/28/2021 |
| FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer | FDA granted accelerated approval to amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) for adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations that progressed on or after platinum-based chemotherapy. | 5/21/2021 |
| FDA approves nivolumab for resected esophageal or GEJ cancer | Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy. | 5/20/2021 |
| FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer | Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. | 5/5/2021 |
| FDA grants accelerated approval to loncastuximab tesirine-lpyl for large B-cell lymphoma | On April 23, 2021, the Food and Drug Administration granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics SA), a CD19-directed antibody and alkylating agent conjugate, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma. | 4/23/2021 |
| FDA grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer | Food and Drug Administration granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen. | 4/22/2021 |
| FDA approves nivolumab in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinoma | Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. | 4/16/2021 |
| FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer | FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer. | 4/13/2021 |
| FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer | Food and Drug Administration granted regular approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. | 4/7/2021 |
| FDA approves new dosing regimen for cetuximab | Food and Drug Administration approved a new dosage regimen of 500 mg/m2 as a 120-minute intravenous infusion every two weeks (Q2W) for cetuximab (Erbitux, ImClone LLC) for patients with K-Ras wild-type, EGFR-expressing colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN). | 4/6/2021 |
| FDA approves isatuximab-irfc for multiple myeloma | Food and Drug Administration approved isatuximab-irfc (Sarclisa, sanofi-aventis U.S. LLC) in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. March 31, 2021 | 3/31/2021 |
| FDA approves idecabtagene vicleucel for multiple myeloma | Food and Drug Administration approved idecabtagene vicleucel (Abecma, Bristol Myers Squibb) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. This is the first FDA-approved cell-based gene therapy for multiple myeloma. March 26, 2021 | 3/26/2021 |
| FDA approves pembrolizumab for esophageal or GEJ carcinoma | Food and Drug Administration approved pembrolizumab (Keytruda, Merck Sharp & Dohme Corp.) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal (GEJ) (tumors with epicenter 1 to 5 centimeters above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation. March 22, 2021. | 3/22/2021 |
| FDA approves tivozanib for relapsed or refractory advanced renal cell carcinoma | Food and Drug Administration approved tivozanib (Fotivda, AVEO Pharmaceuticals, Inc.), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. March 10, 2021 | 3/10/2021 |
| FDA grants accelerated approval to axicabtagene ciloleucel for relapsed or refractory follicular lymphoma | Food and Drug Administration granted accelerated approval to axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. | 3/5/2021 |
| FDA approves lorlatinib for metastatic ALK-positive NSCLC | Food and Drug Administration granted regular approval to lorlatinib (Lorbrena, Pfizer Inc.) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, detected by an FDA-approved test. March 3, 2021 | 3/3/2021 |
| FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma | Food and Drug Administration granted accelerated approval to melphalan flufenamide (Pepaxto, Oncopeptides AB) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibody.Efficacy was evaluated in HORIZON (NCT02963493), a multicenter, single-arm trial. Eligible patients were required to have relapsed refractory multiple myeloma. Patients received melphalan flufenamide 40 mg intravenously on day 1 and dexamethasone 40 mg orally (20 mg for patients ≥75 years of age) on day 1, 8, 15 and 22 of each 28-day cycle until disease progression or unacceptable toxicity. | 2/26/2021 |
| FDA approves cemiplimab-rwlc for non-small cell lung cancer with high PD-L1 expression | Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] > 50%) as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations. | 2/22/2021 |
| FDA approves cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma | Food and Drug Administration approved cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma. | 2/9/2021 |
| FDA approves lisocabtagene maraleucel for relapsed or refractory large B-cell lymphoma | Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. February 5, 2021 | 2/5/2021 |
| FDA grants accelerated approval to umbralisib for marginal zone lymphoma and follicular lymphoma | Food and Drug Administration granted accelerated approval to umbralisib (Ukoniq, TG Therapeutics), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for the following indications: Adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen; Adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. | 2/5/2021 |
| FDA grants accelerated approval to tepotinib for metastatic non-small cell lung cancer | Food and Drug Administration granted accelerated approval to tepotinib (Tepmetko, EMD Serono Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. | 2/3/2021 |
| FDA approves nivolumab plus cabozantinib for advanced renal cell carcinoma | Food and Drug Administration approved the combination of nivolumab (Opdivo, Bristol-Myers Squibb Co.) and cabozantinib (Cabometyx, Exelixis) as first-line treatment for patients with advanced renal cell carcinoma (RCC). | 1/22/2021 |
| FDA grants accelerated approval to Darzalex Faspro for newly diagnosed light chain amyloidosis | Food and Drug Administration granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech Inc.) in combination with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain (AL) amyloidosis. | 1/15/2021 |
| FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas | Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. | 1/15/2021 |
| FDA approves crizotinib for children and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma | Food and Drug Administration approved crizotinib (Xalkori, Pfizer Inc.) for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. | 1/14/2021 |
| FDA approves osimertinib as adjuvant therapy for non-small cell lung cancer with EGFR mutations | Food and Drug Administration approved osimertinib (TAGRISSO, AstraZeneca Pharmaceuticals LP) for adjuvant therapy after tumor resection in patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. | 12/18/2020 |
| FDA approves relugolix for advanced prostate cancer | Food and Drug Administration approved the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix, (ORGOVYX, Myovant Sciences, Inc.) for adult patients with advanced prostate cancer. | 12/18/2020 |
| FDA approves selinexor for refractory or relapsed multiple myeloma | Food and Drug Administration approved selinexor (XPOVIO, Karyopharm Therapeutics Inc.) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. | 12/18/2020 |
| FDA approves margetuximab for metastatic HER2-positive breast cancer | Food and Drug Administration approved margetuximab-cmkb (MARGENZA, MacroGenics) in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. | 12/16/2020 |
| FDA approves pralsetinib for RET-altered thyroid cancers | Food and Drug Administration approved pralsetinib (GAVRETO, Blueprint Medicines Corporation) for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). | 12/1/2020 |
| FDA approves device for treatment of osteoid osteoma in the extremities | Food and Drug Administration approved the Sonalleve MR-HIFU system (Profound Medical Inc.) for the treatment of osteoid osteoma in the extremities. | 11/27/2020 |
| FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow | Food and Drug Administration granted accelerated approval to naxitamab (DANYELZA, Y-mAbs Therapeutics, Inc.) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow demonstrating a partial response, minor response, or stable disease to prior therapy. | 11/25/2020 |
| FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer | Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co.) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test. | 11/13/2020 |
| FDA approves liquid biopsy NGS companion diagnostic test for multiple cancers and biomarkers | Food and Drug Administration approved the liquid biopsy next-generation sequencing-based FoundationOne Liquid CDx test (Foundation Medicine, Inc.) as a companion diagnostic device for multiple additional biomarkers detected in cell free-DNA isolated from plasma specimens. October 26, 2020 and November 6, 2020. | 10/26/2020 |
| FDA Approves Companion Diagnostic to identify NTRK fusions in solid tumors for Vitrakvi | Food and Drug Administration approved the next-generation sequencing (NGS)-based FoundationOne CDx test (Foundation Medicine, Inc.) as a companion diagnostic to identify fusions in neurotrophic receptor tyrosine kinase (NTRK) genes, NTRK1, NTRK2, and NTRK3, in DNA isolated from tumor tissue specimens from patients with solid tumors eligible for treatment with larotrectinib (VITRAKVI, Bayer Healthcare Pharmaceuticals, Inc.). October 26, 2020 | 10/26/2020 |
| FDA grants regular approval to venetoclax in combination for untreated acute myeloid leukemia | Food and Drug Administration grants regular approval to venetoclax in combination for untreated acute myeloid leukemia. | 10/16/2020 |
| FDA extends approval of pembrolizumab for classical Hodgkin lymphoma | Food and Drug Administration extended the approval of pembrolizumab (KEYTRUDA®, Merck Sharp & Dohme Corp.) for the following indications: adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) and pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. | 10/14/2020 |
| FDA approves nivolumab and ipilimumab for unresectable malignant pleural mesothelioma | Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) as first-line treatment for adult patients with unresectable malignant pleural mesothelioma. | 10/2/2020 |
| FDA issues alert about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer | Food and Drug Administration alerted health care professionals and oncology clinical investigators about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer. | 9/8/2020 |
| FDA approves pralsetinib for lung cancer with RET gene fusions | Food and Drug Administration granted accelerated approval to pralsetinib (GAVRETO, Blueprint Medicines Corporation) for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. | 9/4/2020 |
| FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia | Food and Drug Administration approved azacitidine tablets (ONUREG, Celgene Corporation) for continued treatment of patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. | 9/1/2020 |
| FDA Approves Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test | Food and Drug Administration approved the liquid biopsy next-generation sequencing-based FoundationOne Liquid CDx test (Foundation Medicine, Inc.) as a companion diagnostic to identify mutations in BRCA1 and BRCA2 genes in cell free-DNA isolated from plasma specimens from patients with metastatic castration-resistant prostate cancer (mCRPC) eligible for treatment with rucaparib (RUBRACA, Clovis Oncology, Inc.). | 8/26/2020 |
| FDA approves carfilzomib and daratumumab with dexamethasone for multiple myeloma | On August 20, 2020, the Food and Drug Administration approved carfilzomib (KYPROLIS, Onyx Pharmaceuticals, Inc.) and daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. | 8/20/2020 |
| FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma | Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline) for adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. | 8/5/2020 |
| FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma | FDA granted accelerated approval to tafasitamab-cxix (MONJUVI, MorphoSys US Inc.), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant. | 7/31/2020 |
| FDA approves atezolizumab for BRAF V600 unresectable or metastatic melanoma | Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. | 7/30/2020 |
| FDA approves brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma | Food and Drug Administration granted accelerated approval to brexucabtagene autoleucel (TECARTUS, Kite, a Gilead Company), a CD19-directed genetically modified autologous T cell immunotherapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). | 7/24/2020 |
| FDA approves oral combination of decitabine and cedazuridine for myelodysplastic syndromes | Food and Drug Administration approved an oral combination of decitabine and cedazuridine (INQOVI, Astex Pharmaceuticals, Inc.) for adult patients with myelodysplastic syndromes (MDS) including the following: | 7/7/2020 |
| FDA approves avelumab for urothelial carcinoma maintenance treatment | Food and Drug Administration approved avelumab (BAVENCIO, EMD Serono, Inc.) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. | 6/30/2020 |
| FDA approves pembrolizumab for first-line treatment of MSI-H/dMMR colorectal cancer | Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. June 29, 2020 | 6/29/2020 |
| FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer | Food and Drug Administration approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf (PHESGO, Genentech, Inc.) for subcutaneous injection |
6/29/2020 |
| FDA approves pembrolizumab for cutaneous squamous cell carcinoma | Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation | 6/24/2020 |
| Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. | 6/22/2020 | |
| FDA granted accelerated approval to tazemetostat for follicular lymphoma | Food and Drug Administration granted accelerated approval to tazemetostat (TAZVERIK, Epizyme, Inc.), an EZH2 inhibitor, for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treatment options. | 6/18/2020 |
| FDA approves pembrolizumab for adults and children with TMB-H solid tumors | Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. | 6/16/2020 |
| FDA approves gemtuzumab ozogamicin for CD33-positive AML in pediatric patients | Food and Drug Administration extended the indication of gemtuzumab ozogamicin (MYLOTARG, Wyeth Pharmaceuticals LLC) for newly-diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients 1 month and older. | 6/16/2020 |
| FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer | Food and Drug Administration granted accelerated approval to lurbinectedin(ZEPZELCA, Pharma Mar S.A.) for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. June 15, 2020 | 6/15/2020 |
| FDA approves nivolumab for esophageal squamous cell carcinoma | Food and Drug Administration approved nivolumab (OPDIVO, Bristol-Myers Squibb Co.) for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. | 6/10/2020 |
| FDA approves ramucirumab plus erlotinib for first-line metastatic NSCLC | Food and Drug Administration approved ramucirumab (CYRAMZA, Eli Lilly and Company) in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. | 5/29/2020 |
| FDA approves atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma | Food and Drug Administration approved atezolizumab in combination with bevacizumab (TECENTRIQ and AVASTIN, Genentech Inc.) for patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy. | 5/29/2020 |
| FDA approves nivolumab plus ipilimumab and chemotherapy for first-line treatment of metastatic NSCLC | Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. | 5/26/2020 |
| FDA approves brigatinib for ALK-positive metastatic NSCLC | Food and Drug Administration approved brigatinib (ALUNBRIG, ARIAD Pharmaceuticals Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. | 5/22/2020 |
| FDA approves olaparib for HRR gene-mutated metastatic castration-resistant prostate cancer | Food and Drug Administration approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals, LP) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone. | 5/19/2020 |
| FDA approves atezolizumab for first-line treatment of metastatic NSCLC with high PD-L1 expression | Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech Inc.) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), with no EGFR or ALK genomic tumor aberrations. May 18, 2020 | 5/18/2020 |
| FDA approves ripretinib for advanced gastrointestinal stromal tumor | Food and Drug Administration approved ripretinib (QINLOCK, Deciphera Pharmaceuticals, LLC.), for adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. | 5/15/2020 |
| FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer | Food and Drug Administration granted accelerated approval to rucaparib (RUBRACA, Clovis Oncology, Inc.) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. | 5/15/2020 |
| FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%) | Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. | 5/15/2020 |
| FDA grants accelerated approval to pomalidomide for Kaposi sarcoma | Food and Drug Administration expanded the indication of pomalidomide (POMALYST, Celgene Corporation) to include treating adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy and Kaposi sarcoma in adult patients who are HIV-negative. | 5/14/2020 |
| FDA approves olaparib plus bevacizumab as maintenance treatment for ovarian, fallopian tube, or primary peritoneal cancers | Food and Drug Administration expanded the indication of olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals, LP) to include its combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. | 5/8/2020 |
| FDA approves selpercatinib for lung and thyroid cancers with RET gene mutations or fusions | Food and Drug Administration granted accelerated approval to selpercatinib (RETEVMO, Eli Lilly and Company) for the following indications: Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); Adult and pediatric patients ≥12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy; Adult and pediatric patients ≥12 years of age with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). | 5/8/2020 |
| FDA grants accelerated approval to capmatinib for metastatic non-small cell lung cancer | Food and Drug Administration granted accelerated approval to capmatinib (TABRECTA, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. | 5/6/2020 |
| FDA approves daratumumab and hyaluronidase-fihj for multiple myeloma | Food and Drug Administration approved daratumumab and hyaluronidase-fihj (DARZALEX FASPRO, Janssen Biotech, Inc.) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab. May 1, 2020 | 5/1/2020 |
| FDA approves niraparib for first-line maintenance of advanced ovarian cancer | Food and Drug Administration approved niraparib (ZEJULA, GlaxoSmithKline) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. | 4/29/2020 |
| FDA approves new dosing regimen for pembrolizumab | Food and Drug Administration granted accelerated approval to a new dosing regimen of 400 mg every six weeks for pembrolizumab (KEYTRUDA, Merck) across all currently approved adult indications, in addition to the current 200 mg every three weeks dosing regimen. | 4/28/2020 |
| FDA grants accelerated approval to sacituzumab govitecan-hziy for metastatic triple negative breast cancer | Food and Drug Administration granted accelerated approval to sacituzumab govitecan-hziy (TRODELVY, Immunomedics, Inc.) for adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease. | 4/22/2020 |
| FDA approves ibrutinib plus rituximab for chronic lymphocytic leukemia | Food and Drug Administration expanded the indication of ibrutinib (IMBRUVICA, Pharmacyclics LLC) to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). | 4/21/2020 |
| FDA grants accelerated approval to pemigatinib for cholangiocarcinoma with an FGFR2 rearrangement or fusion | Food and Drug Administration granted accelerated approval to pemigatinib (PEMAZYRE, Incyte Corporation) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. | 4/20/2020 |
| FDA approves tucatinib for patients with HER2-positive metastatic breast cancer | Food and Drug Administration approved tucatinib (TUKYSA, Seattle Genetics, Inc.) in combination with trastuzumab and capecitabine, for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. | 4/17/2020 |
| FDA approves mitomycin for low-grade upper tract urothelial cancer | Food and Drug Administration approved mitomycin (JELMYTO™, UroGen Pharma) for adult patients with low-grade upper tract urothelial cancer (LG-UTUC). | 4/15/2020 |
| FDA approves selumetinib for neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas | Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca) for pediatric patients, 2 years of age and older, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). | 4/10/2020 |
| FDA approves encorafenib in combination with cetuximab for metastatic colorectal cancer with a BRAF V600E mutation | Food and Drug Administration approved encorafenib (BRAFTOVI, Array BioPharma Inc.) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy. | 4/8/2020 |
| FDA approves luspatercept-aamt for anemia in adults with MDS | Food and Drug Administration approved luspatercept-aamt (REBLOZYL, Celgene Corporation) for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T). | 4/3/2020 |
| FDA approves durvalumab for extensive-stage small cell lung cancer | Food and Drug Administration approved durvalumab (IMFINZI, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). | 3/30/2020 |
| FDA grants accelerated approval to nivolumab and ipilimumab combination for hepatocellular carcinoma | Food and Drug Administration granted accelerated approval to the combination of nivolumab and ipilimumab (OPDIVO and YERVOY, Bristol-Myers Squibb Co.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. | 3/10/2020 |
| FDA approves isatuximab-irfc for multiple myeloma | Food and Drug Administration approved isatuximab-irfc (SARCLISA, sanofi-aventis U.S. LLC) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. | 3/2/2020 |
| FDA approves neratinib for metastatic HER2-positive breast cancer | Food and Drug Administration approved neratinib (NERLYNX, Puma Biotechnology, Inc.) in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. | 2/25/2020 |
| FDA approves tazemetostat for advanced epithelioid sarcoma | Food and Drug Administration granted accelerated approval to tazemetostat (TAZVERIK, Epizyme, Inc.) for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. | 1/23/2020 |
| FDA approves avapritinib for gastrointestinal stromal tumor with a rare mutation | Food and Drug Administration approved avapritinib (AYVAKIT, Blueprint Medicines Corporation) for adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including D842V mutations. | 1/9/2020 |
| FDA approves pembrolizumab for BCG-unresponsive, high-risk non-muscle invasive bladder cancer | Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co. Inc.) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. | 1/8/2020 |