FDA granted accelerated approval to a combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma.

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 were co-primary endpoints. Opdivo is sponsored by Bristol-Myers Squibb.