Newly Approved Drugs and Indications

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FDA has approved the following new drugs and/or indications in 2013:

  • Denosumab (Xgeva subcutaneous injection) for giant cell tumor of bone.
  • Lenalidomide (Revlimid capsules) for relapsed/refractory mantle cell lymphoma FDA approved.
  • Trametinib (Mekinist tablets) for unresectable or metastatic melanoma with BRAF V600E or V600K mutation.
  • Dabrafenib (Tafinlar capsules) for unresectable or metastatic melanoma with BRAF V600E mutation.
  • Radium Ra 223 dichloride (Xofigo injection) for castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease.  
  • Erlotinib (Tarceva) for first-line treatment of metastatic non-small cell lung cancer patients whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.  This indication for erlotinib was approved concurrently with the cobas EGFR Mutation Test, a companion diagnostic test for patient selection.
  • Ado-trastuzumab emtansine (Kadcyla injection)for single-agent treatment of HER2-positive, metastatic breast cancer previously treated by trastuzumab and a taxane, separately or in combination.  
  • Pomalidomide (Pomalyst capsules) for multiple myeloma patients who have received at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated disease progression on or within 60 days of completion of the last therapy. 
  • Bevacizumab (Avastin) for use in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy for metastatic colorectal cancer that has progressed on a first-line bevacizumab-containing regimen. ■




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