Bristol-Myers Squibb’s Opdivo-Yervoy Combo Nears FDA Approval for MSI-H Colorectal Cancer

Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the U.S. FDA has accepted its filing for Opdivo (nivolumab) combined with Yervoy (ipilimumab) as a first-line treatment for adult and pediatric patients (aged 12+) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC). The FDA set a decision deadline of June 23, 2025, and granted the filing Breakthrough Therapy Designation and Priority Review status.

Regulatory Background
The Opdivo-Yervoy combination was first approved in the U.S. in July 2018 for MSI-H/dMMR mCRC patients who progressed on fluoropyrimidine, oxaliplatin, and irinotecan. The EU approved the combo as a first-line treatment for adults in December 2023, followed by China in October 2023.-Fineline Info & Tech