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What's New (Hematology/Oncology (Cancer) Approvals & Safety Notifications)

For current updates, please see Hematology/Oncology (Cancer) Approvals & Safety Notifications

 

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2011

  • FDA approved asparaginase Erwinia chrysanthemi [Erwinaze, injection, EUSA Pharma (USA), Inc.] as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase. More Information (November 18, 2011)
  • FDA approved ruxolitinib (Jakafi oral tablets, Incyte Corporation) for the treatment of intermediate and high risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis. Results of two randomized controlled trials in patients with intermediate or high risk myelofibrosis comparing ruxolitinib to placebo (Study 1) or to best available therapy (Study 2) were the basis of approval.  More Information (November 16, 2011)
  • FDA approved cetuximab (Erbitux, ImClone LLC, a wholly-owned subsidiary of Eli-Lilly and Company) in combination with platinum-based therapy plus 5-florouracil (5-FU) for the first-line treatment of patients with recurrent locoregional disease and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). More Information (November 7, 2011)
  • FDA granted accelerated approval to deferiprone (Ferriprox Tablets, ApoPharma, Inc.), an oral iron chelator for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. More Information (October 14, 2011)
  • Changes in bevacizumab (Avastin, Genentech, Inc.) package insert regarding: risk of ovarian failure, osteonecrosis of the jaw, risk of venous thromboembolic event (VTE) and bleeding in patients receiving anticoagulation therapy after first VTE event. More Information (September 30, 2011)
  • FDA granted accelerated approval for the use of eculizumab (Soliris, Alexion, Inc.) for the treatment of pediatric and adult patients with atypical hemolytic uremic syndrome (aHUS).  More Information (September 23, 2011)
  • FDA granted approval for denosumab (Prolia, Amgen Inc.) as a treatment to increase bone mass in patients at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer or adjuvant aromatase inhibitor (AI) therapy for breast cancer. In men with nonmetastatic prostate cancer, denosumab also reduced the incidence of vertebral fracture. More Information (September 16, 2011)
  • FDA granted accelerated approval to granted accelerated approval to crizotinib (XALKORI Capsules, Pfizer Inc.) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.  The FDA approved the Vysis ALK Break-Apart FISH Probe Kit (Abbott Molecular, Inc.) concurrently with the crizotinib approval.  This companion diagnostic test is designed to detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in NSCLC. More Information (August 26, 2011)
  • FDA granted accelerated approval to brentuximab vedotin (Adcetris for Injection, Seattle Genetics, Inc.) for two indications: (1) treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates and (2) treatment of patients with systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent chemotherapy regimen.  More Information (August 19, 2011)
  • FDA approved vemurafenib tablets (ZELBORAF, Hoffmann-La Roche Inc.) for the treatment of patients with unresectable or metastatic melanoma with the BRAFV600E mutation as detected by an FDA-approved test.  More Information (August 17, 2011) 
  • FDA approved sunitinib (Sutent Capsules, Pfizer, Inc.) for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable, locally advanced, or metastatic disease. More Information (May 20, 2011)
  • FDA approved everolimus (Afinitor Tablets, Novartis Pharmaceuticals Corporation), for the treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease.  The safety and effectiveness of everolimus in the treatment of patients with carcinoid tumors have not been established. More Information (May 5, 2011)
  • FDA approved abiraterone acetate (Zytiga Tablets, Centocor Ortho Biotech, Inc.) for use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have received prior chemotherapy containing docetaxel.  More Information (April 28, 2011) 
  • FDA approved vandetanib tablets (Vandetanib Tablets, AstraZeneca Pharmaceuticals LP), a kinase inhibitor, for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable, locally advanced, or metastatic disease. The use of vandetanib in patients with indolent, asymptomatic or slowly progressing disease should be carefully considered because of the treatment-related risks of vandetanib.  More Information (April 6, 2011)
  • FDA approved peginterferon alfa-2b (Sylatron, Schering Corporation, Kenilworth, NJ 07033), for the treatment of patients with melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. More Information (March 29, 2011)
  • FDA approved ipilimumab injection (YERVOY, Bristol-Myers Squibb Company) for the treatment of unresectable or metastatic melanoma.  More Information. (March 25, 2011)
  • FDA approved rituximab (Rituxan, Genentech, Inc) for maintenance therapy for patients with previously untreated follicular, CD-20 positive, B-cell non-Hodgkin lymphoma who achieve a response to rituximab in combination with chemotherapy. More Information (January 28, 2011)

2010

  • FDA granted approval for denosumab (Xgeva, Amgen Inc.) for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors.  Denosumab is not indicated for the prevention of SREs in patients with multiple myeloma.  More Information (November 18, 2010)
  • FDA  granted approval for eribulin mesylate (Halaven Injection, Eisai Inc.) for the treatment of patients with metastatic breast cancer who have previously received an anthracycline and a taxane in either the adjuvant or metastatic setting, and at least two chemotherapeutic regimens for the treatment of metastatic disease. More Information (November 15, 2010)
  • This notice is to inform you of important new safety information regarding the already labeled adverse reaction of oligohydramnios (decreased amniotic fluid).  Based on post-marketing adverse event reports, cases of oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death have been reported in the offspring of mothers exposed to trastuzumab (Herceptin, Genentech Incorporated) during pregnancy. More Information (November 1, 2010)
  • FDA granted accelerated approval to everolimus (Afinitor, Novartis), an mTOR inhibitor, for patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS) who require therapy but are not candidates for surgical resection.  Afinitor was originally approved in March 2009 for the treatment of adult patients with advanced renal cell carcinoma (RCC) whose disease was resistant to sunitinib or sorafenib. More Information (October 29, 2010)
  • FDA granted accelerated approval to dasatinib (Sprycel, Bristol-Myers Squibb), an orally administered kinase inhibitor, for the treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (CP-CML).  The recommended dasatinib dose for this indication is 100 mg orally once daily.  Sprycel was originally approved in June 2006 for the treatment of adult patients with CP-CML resistant or intolerant to prior therapy that included imatinib. More Information (October 28, 2010)
  • FDA granted approval for trastuzumab (Herceptin), Genentech, Inc.), in combination with cisplatin and a fluoropyrimidine (capecitabine or 5‑fluorouracil), for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal (GE) junction adenocarcinoma, who have not received prior treatment for metastatic disease.  More Information. (October 20, 2010)
  • This communication is to inform members of the oncology community of recent changes in the measurement of serum creatinine which may have an impact on carboplatin dosing.  Based on preliminary communications with the National Cancer Institute/Cancer Therapy Evaluation Program, a potential safety issue with carboplatin dosing has been identified.   More Information (October 10, 2010).
  • Pfizer Inc., in agreement with the FDA, announced that the commercial marketing of Mylotarg (gemtuzumab ozogamicin) will be voluntarily discontinued, and the new drug application (NDA) for Mylotarg will be withdrawn as of October 15, 2010. More Information (June 21, 2010)
  • FDA granted accelerated approval to nilotinib (Tasigna Capsules, Novartis Pharmaceuticals Corporation), an orally administered kinase inhibitor, for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP-CML). More information (June 17, 2010)
  • FDA approved cabazitaxel (Jevtana Injection, sanofi-aventis) for use in combination with prednisone for treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. More Information (June 17, 2010)
  • FDA approved hexaminolevulinate hydrochloride (Cysview for Intravesical Solution, Photocure ASA), as an optical imaging agent for use in combination with the Karl Storz Photodynamic Diagnostic D-Light C (PDD) System for cystoscopic detection of non-muscle invasive papillary cancer of the bladder for patients suspected or known to have lesion(s) on the basis of a prior cystoscopy.  More Information (May 28, 2010)
  • FDA approved erlotinib (Tarceva) tablets for maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.  More Information (April 16, 2010)
  • FDA has been informed by Lundbeck, Inc., the sole worldwide manufacturer of Mustargen (mechlorethamine HCl for injection), that there will be an extended supply shortage of this drug. More Information (April 9, 2010)
  • FDA granted approval to rituximab (Rituxan, Genentech), in combination with fludarabine and cyclophosphamide (FC), for the treatment of previously untreated and previously treated patients with chronic lymphocytic leukemia (CLL). More Information (February 18, 2010)
  • FDA approved a risk evaluation and mitigation strategy (REMS) to ensure the safe use of Erythropoiesis-Stimulating Agents (ESAs).  The medications included in the program are marketed by Amgen under the names Aranesp (darbepoetin alfa) and Epogen (epoetin alfa) and by Centocor Ortho Biotech Products under the name Procrit (epoetin alfa).  FDA required Amgen, the manufacturer of these products, to develop the REMS based on studies demonstrating that use of ESAs can increase the risk of tumor growth and shorten survival in patients with cancer. More Information (February 16, 2010)
  • FDA granted accelerated approval to Tykerb (lapatinib) tablets for use in combination with letrozole tablets for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. More Information (January 29, 2010)

2009

  • FDA granted approval to romidepsin for injection (ISTODAX, Gloucester Pharmaceuticals Inc.) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. More Information (November 6, 2009)
  • FDA granted accelerated approval to ofatumumab (Arzerra, GlaxoSmithKline) for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab. More Information (October 26, 2009)
  • FDA granted approval to pazopanib tablets (VOTRIENTTM, GlaxoSmithKline) for the treatment of patients with advanced renal cell carcinoma. More Information (October 19, 2009)
  • FDA granted accelerated approval to pralatrexate injection (FOLOTYN, Allos Therapeutics, Inc.) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). More Information (September 24, 2009)
  • FDA granted approval for the use of bevacizumab (Avastin, Genentech, Inc.) in combination with interferon alfa for the treatment of patients with metastatic renal cell carcinoma. More Information (July 31, 2009)
  • FDA implemented Class Labeling Changes to anti-EGFR monoclonal antibodies, cetuximab (Erbitux) and panitumumab (Vectibix): KRAS Mutations changes were made to the product labels of cetuximab (Erbitux  ImClone Systems, Branchburg, NJ) and panitumumab (Vectibix  Amgen, Thousand Oaks, CA). More Information (July 17, 2009) 
  • FDA approved pemetrexed (Alimta) for maintenance treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer patients with no disease progression after four cycles of platinum-based first-line chemotherapy.   More Information (July 2, 2009)
  • FDA approves ferumoxytol (Feraheme Injection, AMAG Pharmaceuticals, Inc.) for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD).  Ferumoxytol is an iron-containing product for intravenous (IV) administration. More Information (June 30, 2009)
  • FDA granted accelerated approval to bevacizumab injection (Avastin, Genentech, Inc.) as a single agent for patients with glioblastoma, with progressive disease following prior therapy. More Information (May 5, 2009)
  • FDA approves everolimus tablets (AFINITOR, Novartis) for treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib More Information (March 31, 2009)

 

2008

  • FDA approved degarelix for injection (Ferring Pharmaceuticals Inc., Parsippany, NJ), a new gonadotropin releasing hormone (GnRH) receptor antagonist, for the treatment of patients with advanced prostate cancer. More Information (December 24, 2008)

     
  • FDA approved imatinib mesylate tablets for oral use (Gleevec, Novartis Pharmaceuticals) for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive Gastrointestinal Stromal Tumor (GIST). More Information (December 19, 2008)

     
  • FDA approved plerixafor, solution for subcutaneous injection, (Mozobil, Genzyme Corp.) for use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM). More Information (December 15, 2008)

     
  • FDA granted accelerated approval for eltrombopag tablets (Promacta, GlaxoSmithKline Inc.) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) More Information (November 20)

     
  • FDA approved bendamustine hydrochloride (TREANDA, Cephalon, Inc.), for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma (NHL) More Information (October 31)

     
  • FDA converted the approval of Denileukin diftitox (Ontak, Eisai Medical Research) solution for intravenous use for the treatment of persistent or recurrent CD-25 positive cutaneous T-cell lymphoma. More information (October 15)

     
  • FDA approves Alimta Injection for Treatment of Metastatic Non-Aquamous Non-Small Cell Lung Cancer (NSCLC).
    More information (October 2)

     
  • FDA approves iobenguane I 123 injection for the detection of primary or metastatic pheochromocytoma or neuroblastoma.
    More information (September 19)

     
  • FDA approves romiplostim (Nplate) for the treatment of thrombocytopenia. More information (August 22)

     
  • Velcade (bortezomib) is approved for initial treatment of Patients with Multiple Myeloma. More information (June 24)

     
  • FDA approves bendamustine hydochloride (Treanda) for the treatment of patients with chronic lymphocytic leukemia (CLL). More information (March 20)

     
  • Bevacizumab (Avastin) was granted accelerated approval for use in combination with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2 negative breast cancer. More information (Feb. 22)

2007

  • FDA approves sorafenib (Nexavar) for the treatment of unresectable hepatocellular carcinoma. More information (Nov. 19)
  • FDA grants accelerated approval of a new dosing regimen of Dasatinib (Sprycel) More information (Nov. 8)
  • FDA approves safety-related product labeling changes for the erythropoiesis-stimulating agents Epogen, Procrit, and Aranesp. (Nov. 8) More information
  • FDA grants accelerated approval to nilotinib (Tasigna) to treat leukemia. More information (Oct. 30)
  • FDA approves ixabepilone for injection (Ixempra) for two indications. More information (Oct. 16)
     
  • FDA expands labeling for cetuximab (marketed as Erbitux). More information (Oct. 2)

     
  • FDA approves new uses for docetaxel (Taxotere). More information (Sep. 28)

     
  • FDA approves new uses for raloxifene hydrochloride (Evista). More information (Sept. 13)

     
  • Dexrazoxane hydrochloride (Totect) was approved for the treatment of anthracycline extravasation. More information (Sept. 6)

     
  • Temsirolimus (Torisel) was approved for the treatment of advanced renal cell carcinoma. More information (May 30)

     
  • Doxorubicin HCl liposome injection (Doxil) was approved for use in combination with bortezomib in patients with multiple myeloma. More information (May 17)

     
  • A new indication for dalteparin sodium injection (Fragmin) was approved. More information (May 1)

     
  • Eculizumab injection (Soliris) was approved for the treatment of paroxysmal nocturnal hemoglobinuria. More information (March 16)

     
  • Lapatinib tablets (Tykerb) was approved for advanced metastatic breast cancer patients. More information (March 13)

     
  • FDA approved labeling changes for erythropoiesis-stimulating agents (ESAs) epoetin alfa (marketed as Procrit, Epogen), darbepoetin alfa (marketed as Aranesp) More information (March 9)

     
  • FDA was notified of the results from a multicenter, double-blind, randomized, placebo-controlled study of darbepoetin alfa (Aranesp) More information (Feb. 22)

     
  • FDA converted approval from accelerated to regular for sunitinib malate (Sutent) for the treatment of advanced renal cell carcinoma. More information (Feb. 2)

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