Bristol-Myers Squibb Announces U.S. FDA Approval For Opdivo (Nivolumab) As A Single Agent For The Treatment Of Patients With Previously Untreated BRAF Wild-Type Advanced Melanoma

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, as a single agent for the treatment of patients with BRAF V600 wild-type (WT) unresectable or metastatic melanoma. The approval is based on data from the Phase 3 trial, CheckMate -066, which evaluated overall survival as the primary endpoint in treatment-naïve patients with BRAF WT unresectable or metastatic melanoma compared to chemotherapy (dacarbazine).