FDA approves Opdivo for MSI-H and dMMR colorectal cancer

FDA granted accelerated approval to PD-1 inhibitor Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY) to treat advanced microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC). Opdivo is indicated for patients ages 12 and older who have progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.

The approval was based on data from the Phase II CheckMate -142 trial, in which Opdivo led to a 28% overall response rate (ORR) in patients with locally determined dMMR or MSI-H mCRC who had progressed on, or were intolerant to, prior chemotherapy...