Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the 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).

Initial results were first presented at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, with additional results presented at the 2025 ASCO Gastrointestinal Cancers Symposium. 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.

Opdivo plus Yervoy received approval from the U.S. FDA in July 2018 for the treatment of adult and pediatric patients 12 years and older with MSI-H or dMMR mCRC that have progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan. Opdivo plus Yervoy was also approved in December 2024 in the European Union for the first-line treatment of adult patients with MSI-H or dMMR unresectable or mCRC and in October 2024 for the same indication by the China National Medical Products Administration (NMPA).