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U.S. Department of Health and Human Services

Drugs

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2012 Notifications

  • FDA granted accelerated approval to ponatinib (Iclusig tablets, ARIAD Pharmaceuticals, Inc.) for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy. More Information21.  December 17, 2012
  • FDA approved an expanded indication for abiraterone acetate (Zytiga Tablets, Janssen Biotech, Inc.) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer. More Information22.  December 10, 2012
  • FDA approved cabozantinib (COMETRIQ capsules, Exelixis, Inc), for the treatment of patients with progressive metastatic medullary thyroid cancer (MTC). Cabozantinib is a small molecule that inhibits the activity of multiple tyrosine kinases, including RET, MET, and VEGF receptor 2. More Information23.  November 29, 2012
  • FDA granted accelerated approval to omacetaxine mepesuccinate, (SYNRIBO for Injection, for subcutaneous use, Teva Pharmaceutical Industries Ltd.), for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs). More Information24.  October 26, 2012
  • FDA approved a 90-minute infusion for rituximab (Rituxan Injection, Genentech, Inc.) starting at Cycle 2 for patients with non-Hodgkin’s lymphoma (NHL) who did not experience a grade 3 or 4 infusion-related adverse reaction during Cycle 1.  Patients with clinically significant cardiovascular disease and high circulating lymphocyte counts (>5000/mcL) are not recommended to receive the faster infusion.  More Information25.  October 19, 2012
  • FDA expanded labeling to include the results of an additional trial evaluating the safety and efficacy of pemetrexed (ALIMTA, Eli Lilly and Company) for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer followed by pemetrexed maintenance in patients whose disease has not progressed after four cycles of platinum and pemetrexed as first-line chemotherapy. More Information26.  October 17, 2012
  • FDA approved paclitaxel protein-bound particles for injectable suspension, albumin-bound (ABRAXANE for Injectable Suspension; Abraxis Bioscience a wholly owned subsidiary of Celgene Corporation) for use in combination with carboplatin for the initial treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not candidates for curative surgery or radiation therapy.  More Information27.  October 11, 2012
  • FDA approved regorafenib (Stivarga tablets, Bayer HealthCare Pharmaceuticals, Inc.), for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. More Information28.  September 27, 2012
  • FDA approved bosutinib tablets (Bosulif, Pfizer, Inc.) for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior therapy. More Information.29  September 4, 2012
  • FDA approved enzalutamide (XTANDI Capsules, Medivation, Inc. and Astellas Pharma US, Inc.), for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. More Information30.  August 31, 2012
  • FDA granted accelerated approval for everolimus tablets for oral suspension (Afinitor Disperz, Novartis Pharmaceuticals Corp.) for the treatment of pediatric and adult patients with tuberous sclerosis complex (TSC) who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. More Information31. August 30, 2012
  • FDA granted accelerated approval for vinCRIStine sulfate LIPOSOME injection (Marqibo, Talon Therapeutics, Inc.) for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies.  More Information32.  August 9, 2012
  • FDA approved ziv-aflibercept injection (ZALTRAP, Sanofi U.S., Inc.) for use in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI) for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin containing regimen. More Information33.  August 3, 2012
  • FDA approved everolimus tablets (Afinitor®, Novartis Pharmaceuticals Corporation) for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole. More Information.34  July 20, 2012
  • FDA granted accelerated approval to carfilzomib injection (Kyprolis, Onyx Pharmaceuticals), for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of the completion of the last therapy.  More Information35.  July 20, 2012
  • FDA granted approval to cetuximab (Erbitux, ImClone LLC, a wholly owned subsidiary of Eli Lilly and Co) for use in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment of patients with K-ras mutation-negative (wild-type), EGFR-expressing metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use.
    FDA also approved the Therascreen KRAS RGQ PCR Kit (QIAGEN Manchester, Ltd) concurrent with this cetuximab approval. More Information36.  July 9, 2012
  • FDA approved pertuzumab injection (PERJETA, Genentech, Inc.) for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (Subdomain II) of HER2, and thereby blocks ligand-dependent heterodimerization of HER2 with other HER family members, including EGFR, HER3 and HER4. More Information37.  June 8, 2012
  • FDA approved pazopanib tablets (VOTRIENT, a registered Trademark of GlaxoSmithKline) for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy.  The efficacy of pazopanib for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors (GIST) has not been demonstrated. More Information38.  April 26, 2012 
  • FDA granted accelerated approval to everolimus (Afinitor tablets, Novartis) for the treatment of adults with renal angiomyolipoma, associated with tuberous sclerosis complex (TSC), who do not require immediate surgery. More Information39.  April 26, 2012
  • FDA announced major actions taken to bolster the supply of Doxil (Janssen Research and Development LLC) and preservative-free formulations of methotrexate.  In response to the critical shortage of Doxil (doxorubicin hydrochloride liposome injection) effective immediately FDA is exercising its enforcement discretion for the temporary importation and distribution of Sun Pharma Global's Lipodox.  More Information40 February 21, 2012
  • FDA granted regular approval for imatinib mesylate tablets (Gleevec, Novartis Pharmaceuticals) for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive Gastrointestinal Stromal Tumors (GIST). Accelerated approval for this indication was granted in December 2008. Labeling is also revised to include the results of a randomized trial demonstrating that recurrence-free survival (RFS) and overall survival (OS) were improved by continuing adjuvant imatinib therapy to 36 months. More Information41 (January 31, 2012)
  • FDA approved vismodegib (ERIVEDGE Capsule, Genentech, Inc.) for the treatment of adults with metastatic basal cell carcinoma or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.  More Information42 (January 30, 2012)
  • FDA approved axitinib tablets (Inlyta, Pfizer, Inc.) for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy. More Information43 (January 27, 2012)
  • FDA approved glucarpidase  injection (Voraxaze, BTG International Inc.) for the treatment of toxic plasma methotrexate concentrations (> 1 μmol/L) in patients with delayed methotrexate clearance due to impaired renal function. More Information44 (January 17, 2012)