SIDEBAR: FDA Drug Approvals, 2013


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  • Ibrutinib (Imbruvica) for mantle cell lymphoma
  • Obinutuzumab (Gazyva) for chronic lymphocytic leukemia
  • Pertuzumab (Perjeta) for breast cancer
  • Paclitaxel protein-bound particles (Abraxane) for pancreatic adenocarcinoma
  • Afatinib (Gilotrif) for non-small cell lung cancer, with Therascreen EGFR RGQ PCR Kit (Qiagen) test
  • Denosumab (Xgeva) for giant cell tumor of bone
  • Lenalidomide (Revlimid) for mantle cell lymphoma
  • Trametinib (Mekinist) for melanoma
  • Dabrafenib (Tafinlar) for melanoma
  • Radium RA 223 dichloride (Xofigo injection) for prostate cancer bone metastases
  • Erlotinib (Tarceva) for non-small cell lung cancer, with Cobas EGFR Mutation Test 
  • Ado-trastuzumab emtansine (Kadcyla) for breast cancer
  • Pomalidomicde (Pomalyst) for multiple myeloma
  • Doxorubicin hydrochloride liposome injection (generic Doxil Injection) for ovarian cancer
  • Bevacizumab (Avastin) for colorectal cancer

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FDA Approves Ibrutinib for Mantle Cell Lymphoma

The U.S. Food and Drug Administration has approved ibrutinib (Imbruvica) to treat patients with mantle cell lymphoma, a rare and aggressive form of non-Hodgkin lymphoma representing about 6% of all non-Hodgkin lymphoma cases in the United States. By the time mantle cell lymphoma is diagnosed, it...


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