Bristol-Myers Squibb announced that 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. Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor, and works by targeting the immune system through the PD-1 immune checkpoint pathway.

Adverse events: In a clinical trial, the most common adverse reaction (≥20%) reported with OPDIVO was rash (21%). The most common adverse reactions (≥20%) reported with OPDIVO vs dacarbazine were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In another clinical trial, the most common adverse reactions (≥20%) reported with OPDIVO were fatigue (49%), musculoskeletal pain (36%), cough (30%), decreased appetite (29%), and constipation (23%). The most common adverse reactions (≥20%) reported in patients receiving OPDIVO in combination with YERVOY vs YERVOY alone were rash (67% vs 57%), pruritus (37% vs 26%), headache (24% vs 20%), vomiting (23% vs 15%), and colitis (22% vs 11%).

Citation: Bristol-Myers Squibb announces U.S. Food and Drug Administration approval for Opdivo (nivolumab) as a single agent for the treatment of patients with previously untreated BRAF wild-type advanced melanoma. [news release]. Princeton, NJ: Bristol-Myers Squibb; November 24, 2015. http://news.bms.com/press-release/bristol-myers-squibb-announces-us-food-and-drug-administration-approval-opdivo-nivolum. Accessed November 24, 2015.