Health Canada Approves OPDIVO + YERVOY as First-Line Treatment for Colorectal and Liver Cancers

Bristol Myers Squibb (BMS) Canada has announced that Health Canada has approved the dual immunotherapy combination of OPDIVO® (nivolumab) plus YERVOY® (ipilimumab) for the first-line treatment of:

• Unresectable or metastatic microsatellite instability-high (MSI-H) / mismatch repair deficient (dMMR) colorectal cancer (CRC)

• Unresectable or advanced hepatocellular carcinoma (HCC)

The approvals are based on results from pivotal Phase 3 studies:

• CheckMate-8HW in CRC, which showed a 79% reduction in risk of progression or death compared to chemotherapy.

• CheckMate-9DW in HCC, which demonstrated a significant overall survival benefit compared to tyrosine kinase inhibitors.

Oncologists across Canada emphasized the importance of these new options for patients with aggressive and hard-to-treat cancers. Patient advocacy groups, including Colorectal Cancer Canada, CCRAN, and Liver Canada, welcomed the approvals, highlighting the urgent need for more effective treatments and the hope this dual immunotherapy brings.

Elaine Phillips, General Manager of BMS Canada, stated: “These approvals expand access to a proven dual immunotherapy approach for two distinct gastrointestinal cancers with high unmet need, underscoring our commitment to advancing innovative treatments that deliver real-world impact.”