BMS gets nod for Empliciti, denial for Opdivo

FDA approved Empliciti elotuzumab from Bristol-Myers Squibb Co. (NYSE:BMY) and AbbVie Inc. (NYSE:ABBV) to treat multiple myeloma (MM). The agency also issued a complete response letter for BMS's Opdivo nivolumab as a single agent for previously untreated patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

FDA approved Empliciti in combination with Revlimid lenalidomide from Celgene Corp. (NASDAQ:CELG) and dexamethasone to treat MM in patients who have received one to three prior therapies. BMS, which is to lead commercialization of the drug, plans to launch Empliciti within two days at a wholesale acquisition cost (WAC) of about $10,000 per month, or $142,000 for the first year of treatment including a two-month induction period. The approval came three months ahead of Empliciti's Feb. 29, 2016, PDUFA date. ...