2011 in Review: Oncology Drugs/Indications Newly Approved by FDA


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FDAlogoAt press time, the FDA had granted approval for the following new agents and indications for cancer treatment in 2011.

  • Asparaginase Erwinia chrysanthemi (Erwinaze) as a component of a multiagent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in patients who have developed hypersensitivity to E coli–derived asparaginase. November 18, 2011
  • Ruxolitinib (Jakafi) for intermediate and high-risk myelofibrosis, including primary myelofibrosis, postpolycythemia vera myelofibrosis, and post–essential thrombocythemia myelofibrosis. November 16, 2011
  • Cetuximab (Erbitux) in combination with platinum-based therapy plus fluorouracil for the first-line treatment of patients with recurrent locoregional disease and/or metastatic squamous cell carcinoma of the head and neck.  November 7, 2011
  • Deferiprone (Ferriprox), an oral iron chelator for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. October 14, 2011
  • Eculizumab (Soliris) for the treatment of pediatric and adult patients with atypical hemolytic uremic syndrome.  September 23, 2011
  • Denosumab (Prolia) as a treatment to increase bone mass in patients at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer. September 16, 2011
  • Crizotinib (Xalkori) for 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 concurrently with the crizotinib approval.  This companion diagnostic test is designed to detect rearrangements of the anaplastic lymphoma kinase gene in NSCLC. August 26, 2011
  • Brentuximab vedotin (Adcetris) for: (1) treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multiagent chemotherapy regimens in patients who are not ASCT candidates and (2) treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multiagent chemotherapy regimen. August 19, 2011
  • Vemurafenib (Zelboraf) for unresectable or metastatic melanoma in patients with the BRAFV600E mutation as detected by an FDA-approved test. August 17, 2011
  • Sunitinib (Sutent) for pancreatic neuroendocrine tumors (pNET) in patients with unresectable, locally advanced, or metastatic disease. May 20, 2011
  • Everolimus (Afinitor), for progressive neuroendocrine tumors of pancreatic origin in patients with unresectable, locally advanced, or metastatic disease. May 5, 2011
  • Abiraterone acetate (Zytiga) for use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel. April 28, 2011
  • Vandetanib (Caprelsa), a kinase inhibitor, for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable, locally advanced, or metastatic disease. April 6, 2011
  • Peginterferon alfa-2b (Sylatron), for patients with melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. March 29, 2011
  • Ipilimumab (Yervoy) for the treatment of unresectable or metastatic melanoma. March 25, 2011
  • Rituximab (Rituxan) 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. January 28, 2011

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