FDAnews Drug Daily Bulletin

BMS’ Colorectal Cancer Drug Gets Accelerated Approval

Aug. 7, 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.

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