Drugs

Hematology/Oncology (Cancer) Approvals & Safety Notifications

Sign up for free updates from FDA

2017

  • FDA granted regular approval to pembrolizumab (KEYTRUDA, Merck and Co., Inc.) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. More Information.  May 18, 2017
  • FDA granted accelerated  approval to pembrolizumab (KEYTRUDA, Merck and Co., Inc.) in combination with pemetrexed and carboplatin for the  treatment of patients with previously untreated metastatic non-squamous non-small  cell lung cancer (NSCLC). More Information. May 10, 2017
  • FDA granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. More Information.  May 9, 2017
  • FDA granted accelerated approval to durvalumab (IMFINZI, AstraZeneca UK Limited) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.  More Information. May 1, 2017
  • FDA granted accelerated approval to brigatinib (ALUNBRIG tablets, Takeda Pharmaceutical Company Limited, through its wholly owned subsidiary ARIAD Pharmaceuticals, Inc.) for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. More Information.  April 28, 2017
  • FDA approved midostaurin (RYDAPT, Novartis Pharmaceuticals Corp.) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive (FLT3+), as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. More Information.  April 28, 2017
  • FDA expanded the indications of regorafenib (STIVARGA, Bayer HealthCare Pharmaceuticals Inc.) to include the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. More Information.  April 27, 2017
  • FDA has permitted marketing of the Philips IntelliSite Pathology Solution (PIPS, Philips Medical Systems Nederland B.V.), as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. More Information.  April 17, 2017
  • FDA has granted marketing authorization to  ipsogen JAK2 RGQ PCR Kit, manufactured by QIAGEN GmbH., to detect mutations affecting the Janus Tyrosine Kinase 2 (JAK2) gene. This is the first FDA-authorized test intended to help physicians in evaluating patients for suspected Polycythemia Vera (PV).  More Information.  March 27, 2017
  • FDA granted regular approval to palbociclib (IBRANCE, Pfizer Inc.) for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women. More Information.  March 31, 2017
  • FDA granted regular approval to osimertinib (TAGRISSO, AstraZeneca Pharmaceuticals, LP) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. More Information.  March 30, 2017
  • FDA approved niraparib (ZEJULA, Tesaro, Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. More Information.  March 27, 2017
  • FDA granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.) for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma (MCC). Avelumab is a programmed death-ligand 1 (PD-L1) blocking human IgG1 lambda monoclonal antibody. This is the first FDA-approved product to treat this type of cancer. More Information.  March 23, 2017
  • FDA granted accelerated approval to pembrolizumab (KEYTRUDA), Merck and Co., Inc.) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy. More Information.  March 15, 2017
  • FDA approved ribociclib (KISQALI, Novartis Pharmaceuticals Corp.), a cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. More Information.  March 13, 2017
  • FDA approved lenalidomide (Revlimid, Celgene Corp.) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant. More Information.  February 22, 2017
  • FDA granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Company) for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy. More Information.  February 2, 2017

 

 2016 

  • FDA granted accelerated approval to rucaparib (RUBRACA, Clovis Oncology, Inc.) for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies.  More Information.  December 19, 2016
  • FDA approved daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.  More Information.  November 21, 2016
  • FDA approved nivolumab (OPDIVO Injection, Bristol-Myers Squibb Company), for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.  More Information.  November 10, 2016
  • FDA approved pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test.  More Information.  October 24, 2016
  • FDA granted accelerated approval to olaratumab (LARTRUVO, Eli Lilly and Company) for the treatment of patients with soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery and with a histologic subtype for which an anthracycline-containing regimen is appropriate.  More Information.  October 19, 2016
  • FDA approved atezolizumab (TECENTRIQ, Genentech Oncology) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving atezolizumab.  More Information.  October 18, 2016
  • FDA modified the indication for erlotinib (TARCEVA, Astellas Pharm Global Development Inc.) for treatment of non-small cell lung cancer (NSCLC) to limit use to patients whose tumors have specific epidermal growth factor receptor (EGFR) mutations. More Information. October 18, 2016
  • FDA modified the dosage regimen for nivolumab (Opdivo, Bristol-Myers Squibb Co.) for the currently approved indications for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer.  The currently approved recommended dosage regimens were modified to 240 mg intravenously (IV) every two weeks.  More Information.  September 13, 2016.
  • FDA granted accelerated approval to pembrolizumab (KEYTRUDA injection, Merck Sharp & Dohme Corp.) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. More Information. August 5, 2016
  • FDA approved cobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.) using plasma specimens as a companion diagnostic test for the detection of exon 19 deletions or exon 21 (L858R) substitution mutations in the epidermal growth factor receptor (EGFR) gene to identify patients with metastatic non-small cell lung cancer (NSCLC) eligible for treatment with Tarceva (erlotinib). More Information.  June 1, 2016
  • FDA gave accelerated approval to atezolizumab injection (Tecentriq, Genentech, Inc.) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.   Atezolizumab is a programmed death-ligand 1 (PD-L1) blocking antibody. More Information.  May 18, 2016
  • FDA granted accelerated approval to nivolumab (Opdivo, marketed by Bristol-Myers Squibb) for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin (Adcetris).  More Information.  May 17, 2016
  • FDA approved lenvatinib capsules (Lenvima, Eisai, Inc.), in combination with everolimus, for the treatment of advanced renal cell carcinoma following one prior anti-angiogenic therapy.  Lenvatinib was first approved in 2015 for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. More Information.  May 13, 2016
  • FDA approved cabozantinib (CABOMETYX, Exelixis, Inc.) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy. More Information.  April 25, 2016
  • FDA approved venetoclax (VENCLEXTA  tablets, marketed by AbbVie, Inc. and Genentech USA, Inc.) for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. More Information.  April 11, 2016
  • FDA approved defibrotide sodium (Defitelio, Jazz Pharmaceuticals, Inc.) for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstructive syndrome, with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT). More Information.  March 30, 2016.
  • FDA approved crizotinib capsules (Xalkori, Pfizer, Inc.) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. More Information.  March 11, 2016
  • FDA approved everolimus (Afinitor , Novartis) for the treatment of adult patients with progressive, well-differentiated non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease.  More Information.  February 26, 2016
  • FDA  approved obinutuzumab (Gazyva Injection, Genentech, Inc.) for use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen. Obinutuzumab was previously approved for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia. More Information.  February 26, 2016
  • FDA  approved palbociclib (IBRANCE Capsules, Pfizer, Inc.) in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. More Information.  February 19, 2016
  • FDA approved eribulin (HALAVEN® injection, Eisai Co., Ltd.) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. More Information.  January 28, 2016
  •  FDA approved ofatumumab (Arzerra Injection, Novartis Pharmaceuticals Corporation) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab was previously approved for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy was considered inappropriate and also for patients with CLL refractory to fludarabine and alemtuzumab.  More Information.  January 19, 2016
 
To view 2006-2015 archived approval information, please see the FDA Archive.
 
 
 

 Sign Up for Free Updates from FDA

  • OHOP Email updates: To receive email notification of new approvals, meetings, presentations, and other information from OHOP,   follow this link and complete the form.  
  • RSS (Really Simple Syndication) Feed:  Internet technology that enables easy distribution of news and other Web content. Users can access the material through a news reader or “aggregator,” which downloads and displays the feeds. Users are able to get automatic updates on news items on new approvals, meetings, and other announcements.    

 

Page Last Updated: 05/18/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English