FDA clears new indication for Bristol-Myers' Opdivo

• The FDA approves Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) as a single agent for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. The data supporting clearance was generated in the Phase 3 Checkmate-066 study which compared Opdivo to chemotherapy (dacarbazine) in the target population.
• The company's supplemental BLA for Opdivo in BRAF V600+ unresectable or metastatic melanoma is still under FDA review.