FDA approves Opdivo and Yervoy (nivolumab + ipilimumab) for BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma- BMS

Bristol-Myers Squibb has announced that the 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. This indication is approved 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.

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 III CheckMate -067 trial, in which PFS and overall survival (OS) were co-primary endpoints.