Bristol-Myers confirms FDA approval of Opdivo Bristol-Myers Squibb Company announced that the FDA approved Opdivo injection, for intravenous use. Opdivo is a human programmed death receptor-1 blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The company expects to begin shipping Opdivo within one to two weeks of today’s approval.