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FDA approves Celgene's pomalidomide

February 9, 2013 2:05 AM UTC

FDA granted accelerated approval to Pomalyst pomalidomide from Celgene Corp. (NASDAQ:CELG) to treat patients with multiple myeloma (MM). The drug is approved for MM patients who have received at least two prior therapies including Velcade bortezomib and Celgene's Revlimid lenalidomide, and who have demonstrated disease progression on or within 60 days of completion of the last therapy. Pomalyst's label includes a boxed warning about the risk of embryo-fetal toxicity and venous thromboembolism. The thalidomide analog is available only through a REMS program that requires women of reproductive age to comply with pregnancy testing and contraception requirements. An MAA for Pomalyst is under review in Europe, with a decision expected next half.

Last July, FDA granted accelerated approval to Kyprolis carfilzomib from Onyx Pharmaceuticals Inc. (NASDAQ:ONXX) to treat MM patients who have progressed after at least two therapies including bortezomib and an immunomodulatory agent (see BioCentury Extra, July 20, 2012). ...