Bristol Myers Squibb (BMY) announced 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 potential first-line treatment 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 application has been granted Breakthrough Therapy Designation and Priority Review status, with a Prescription Drug User Fee Act (PDUFA) target action date set for June 23, 2025.

The FDA’s acceptance is based on results from the Phase 3 CheckMate -8HW trial, which demonstrated that Opdivo plus Yervoy achieved superior progression-free survival compared to both Opdivo monotherapy and investigator’s choice of chemotherapy. The combination therapy has already received regulatory approvals for similar indications in the European Union and China in late 2024.

Mismatch repair deficiency (dMMR) and microsatellite instability-high (MSI-H) tumors affect approximately 5-7% of metastatic colorectal cancer patients. These patients typically do not respond well to conventional chemotherapy and often have poorer prognoses, making immunotherapy-based treatments a crucial alternative.

Bristol Myers Squibb’s application brings the company one step closer to establishing a new standard of care for MSI-H/dMMR mCRC. The CheckMate -8HW study continues to evaluate secondary endpoints, including overall survival.

**Source: Bristol Myers Squibb, "FDA Accepts Bristol Myers Squibb’s Supplemental Biologics License Application for Opdivo® Plus Yervoy®," February 24, 2025.**