Bristol-Myers Squibb's Opdivo + Yervoy Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status1

Bristol-Myers Squibb Company BMY announced Saturday, that the U.S. Food and Drug Administration (FDA) has approved 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.1 This indication is approved under accelerated approval based on progression-free survival (PFS).1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1 This approval expands the original indication for the Opdivo + Yervoy Regimen for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma to include patients, regardless of BRAF mutational status, based on data from the Phase 3 CheckMate -067 See full press release