On December 22, 2014, the FDA granted accelerated approval to nivolumab (OPDIVO; 
Bristol-Myers Squibb) for the treatment of patients with unresectable or 
metastatic melanoma and disease progression following ipilimumab and, if BRAF 
V600 mutation positive, a BRAF inhibitor. Approval was based on a clinically 
meaningful, durable objective response rate (ORR) in a non-comparative analysis 
of 120 patients who received 3 mg/kg of nivolumab intravenously every 2 weeks 
with at least 6-month follow-up in an ongoing, randomized, open-label, 
active-controlled clinical trial. The ORR as assessed by a blinded independent 
review committee per RECIST v1.1 was 31.7% (95% confidence interval, 23.5-40.8). 
Ongoing responses were observed in 87% of responding patients, ranging from 2.6+ 
to 10+ months. In 13 patients, the response duration was 6 months or longer. The 
risks of nivolumab, including clinically significant immune-mediated adverse 
reactions (imARs), were assessed in 268 patients who received at least one dose 
of nivolumab. The FDA review considered whether the ORR and durations of 
responses were reasonably likely to predict clinical benefit, the adequacy of 
the safety database, and systematic approaches to the identification, 
description, and patient management for imARs in product labeling. Clin Cancer 
Res; 23(14); 3484-8. ©2017 AACR.