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FDA approves BMS's Opdivo for advanced melanoma

December 23, 2014 4:11 AM UTC

FDA granted accelerated approval to Opdivo nivolumab from Bristol Myers-Squibb Co. (NYSE:BMY) to treat unresectable or metastatic melanoma in patients previously treated with the company's Yervoy ipilimumab, and if BRAF V600 mutation-positive, Yervoy plus a BRAF inhibitor. The approval came well ahead of the drug's March 30, 2015, PDUFA date.

BMS plans to launch Opdivo within the next two weeks at a cost of $12,500 per month. A course of treatment would cost about $66,250 based on a median duration of treatment of 5.3 months included in the label. ...