FDA expands approval for Opdivo + Yervoy combo

The US Food and Drug Administration has approved 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 and BRAF V600 mutation-positive unresectable or metastatic melanoma.

Bristol-Myer’s share closed up just over 2% at $64.41 on Friday following release of the news.

This indication is cleared under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, the company said. This approval expands the original indication for the Opdivo + Yervoy Regimen for the treatment of people with BRAF V600 wild-type unresectable or metastatic melanoma to include patients, regardless of BRAF mutational status, based on data from the Phase III CheckMate -067 trial, in which PFS and overall survival (OS) were co-primary endpoints.