Global biopharmaceutical company Bristol-Myers Squibb (BMS, NYSE: BMY) has announced that it has received marketing approval from the European Commission (EC) for its combination therapy of Opdivo (nivolumab) and Yervoy (ipilimumab). This treatment is indicated for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC). This endorsement follows a similar approval in China in October 2024, marking the combination’s first global approval.
CheckMate-8HW Study Results Support EC Approval
The EC’s decision to grant approval is supported by the positive results from the CheckMate-8HW study. In this study, the combination of Opdivo and Yervoy demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoint of progression-free survival (PFS). The study also showed that the combination reduced the risk of disease progression or death by 79% compared to the investigator’s choice of chemotherapy, highlighting the potential benefits of this immunotherapy combination for patients with MSI-H/mCRC.-Fineline Info & Tech
