The FDA granted accelerated approval to Bristol-Myers Squibbs’ metastatic colorectal cancer drug Opdivo (nivolumab).

The agency based its decision on data from a single-arm, open-label study of 53 patients with locally determined dMMR or MSI-H metastatic colorectal cancer progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

No trials were conducted for pediatric patients but the accelerated approval applied to patients 12 years and older.