The U.S. Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s supplemental biologics license application (sBLA) for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a potential first-line treatment option for adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC).

The FDA granted the application Breakthrough Therapy Designation and Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025.

“Today’s milestone brings us one step closer to providing an effective dual immunotherapy treatment option to adult and pediatric patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer,” said Dana Walker, M.D., M.S.C.E., vice president, Opdivo global program lead, Bristol Myers Squibb. “We look forward to potentially bringing a new standard of care treatment option to this patient population.”

The application was based on results from the three-arm Phase 3 CheckMate -8HW study demonstrating that Opdivo plus Yervoy met the dual primary endpoints of progression free survival (PFS) compared to investigator’s choice of chemotherapy in the first-line setting and compared to Opdivo monotherapy across all lines of therapy, as assessed by Blinded Independent Central Review (BICR).

The safety profile for the dual immunotherapy combination remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified. The study is ongoing to assess secondary endpoints, including overall survival.