Additionally, this combination is approved for the treatment of unresectable or advanced hepatocellular carcinoma (HCC).
The approval introduces a dual immunotherapy option for two difficult-to-treat gastrointestinal cancers.
Evidence supporting the decision comes from two Phase III trials: CheckMate-8HW in colorectal cancer, which showed improvement in progression-free survival, and CheckMate-9DW in HCC, which demonstrated a survival benefit compared to current standard therapies.
Bristol Myers Squibb Canada general manager Elaine Phillips said: “These approvals underscore our continued focus on advancing immunotherapy where it can make a meaningful difference.
“By introducing Opdivo plus Yervoy as a first-line treatment option for these two distinct and challenging gastrointestinal cancers, we are expanding access to a dual immunotherapy approach in areas with significant unmet need. This milestone reflects our commitment to delivering innovative science with real-world impact.”
The company first introduced immunotherapy in Canada in 2012 with Yervoy, followed by a dual regimen of Opdivo plus Yervoy in 2016.
The latest approval extends the use of this combination to colorectal and liver cancer patients.
In the CheckMate 8HW trial, the combination demonstrated a significant reduction in the risk of disease progression or death by 79% when compared to chemotherapy in patients with MSI-H/dMMR metastatic colorectal cancer.
Meanwhile, in CheckMate 9DW, this combination therapy also exhibited a survival advantage over tyrosine kinase inhibitors for patients with advanced HCC.