FDA approves Bristol-Myers' Opdivo + Yervoy for metastatic melanoma

The US Food and Drug Administration today approved US pharma major Bristol-Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) in combination with Yervoy (ipilimumab), for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

Today’s announcement marks the first and only FDA approval of a regimen of two immuno-oncology agents in cancer, says B-MS. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Opdivo and Yervoy are already approved as monotherapy and had total sales of $783 million in the first half of this year. News of the combination regimen approval lifted B-MS’ share more than 1% to $59.83 in mid-morning New York trading.