Biopharmaceutical company Bristol Myers Squibb (NYSE: BMY) announced on Monday that the U.S. Food and Drug Administration (FDA) has accepted its supplemental biologics license application (sBLA) for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for adults and paediatric patients (12+) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC). The FDA granted Breakthrough Therapy Designation and Priority Review, setting a target decision date of 23 June 2025.

The application is backed by data from the Phase 3 CheckMate -8HW trial, where the Opdivo-Yervoy combination demonstrated superior progression-free survival compared to both Opdivo monotherapy and chemotherapy. Findings were initially presented at the 2024 ASCO Gastrointestinal Cancers Symposium, with further data disclosed at the 2025 event. Safety outcomes remained consistent with previous reports.

Opdivo plus Yervoy was previously approved by the FDA in 2018 for patients with MSI-H or dMMR mCRC following prior treatment and received European Union approval in December 2024 for first-line use. China's National Medical Products Administration granted approval for the same indication in October 2024.

Bristol Myers Squibb continues to advance its immunotherapy pipeline, leveraging its expertise in oncology research to expand treatment options across multiple cancer types.