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European Commission Approves Opdivo® Plus Yervoy® for First-Line Treatment of MSI-H or dMMR mCRC

NextEdge Admin

24 Dec 2024

2 min 12 sec

European Commission,mismatch repair deficient,colorectal cancer

Bristol Myers Squibb (NYSE: BMY) announced that the European Commission (EC) has approved Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) 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 approval addresses the significant unmet need in colorectal cancer, the second leading cause of cancer death in Europe. Around 5-7% of mCRC patients have MSI-H/dMMR tumors, which are less responsive to conventional chemotherapy and typically result in poor prognosis.

The approval is based on the CheckMate -8HW trial, where Opdivo plus Yervoy demonstrated a statistically significant improvement in progression-free survival (PFS). The combination reduced the risk of disease progression or death by 79% compared to the investigator’s choice of chemotherapy, as assessed by Blinded Independent Central Review (BICR). The safety profile of the dual immunotherapy combination was consistent with previous studies, and no new safety concerns were identified.

This decision is valid across all 27 European Union (EU) member states, along with Iceland, Liechtenstein, and Norway. Opdivo-based therapies are also approved for several other cancer types in the EU. Dr. Dana Walker, VP of the Opdivo global program, emphasized that this approval represents a significant advancement for patients with MSI-H or dMMR mCRC, offering a new treatment option that can delay disease progression and improve outcomes.