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# Bristol-Myers Squibb sBLA for Colorectal Cancer
- URL: https://www.fdaweb.com/bristol-myers-squibb-sbla-for-colorectal-cancer/
- Published: 2018-03-29T12:00:00.000Z
- Updated: 2026-09-14T23:56:00.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5141106

FDA has accepted for review a Bristol-Myers Squibb supplemental BLA for Opdivo(nivolumab) in combination with Yervoy (ipilimumab) for treating adults with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan. The agency has set a user fee review action target date of 7/10.

The submission is based on data from the ongoing Phase 2 CheckMate-142 study evaluating the drug combination in previously treated patients. Data from the study showed a 55% overall response rate and 80% disease control rate.