www.fdanews.com/articles/182910-bms-colorectal-cancer-drug-gets-accelerated-approval
BMS’ Colorectal Cancer Drug Gets Accelerated Approval
August 4, 2017
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.