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# Opdivo Accelerated Approval for Colorectal Cancer
- URL: https://www.fdaweb.com/opdivo-accelerated-approval-for-colorectal-cancer/
- Published: 2017-08-01T12:00:00.000Z
- Updated: 2026-09-14T22:37:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139272

FDA has granted Bristol-Myers Squibb accelerated approval for Opdivo (nivolumab) for treating patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan. Approval was based on data from the CHECKMATE 142 study, a multicenter, single arm study conducted in 53 patients with locally determined dMMR or MSI-H metastatic colorectal cancer who had disease progression during, after, or were intolerant to prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. The objective response rate as assessed by independent radiographic review was 28% (n=15) in the 53 patients who received prior fluoropyrimidine, oxaliplatin, and irinotecan, an [agency release](https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm569366.htm?ref=fdaweb.com) says. Responses lasted six or more months for 67% of patients. Additionally, There was one complete response and 14 partial responses.