Bristol Myers Squibb Co. (BMY) announced Monday that the European Medicines Agency (EMA) has validated its Type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).
The EMA's validation of the application confirms the submission is complete and begins the EMA's centralized review process.
The submission is based on results from the CheckMate -8HW study, in which Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoint of progression-free survival (PFS).
This was compared to investigator's choice of chemotherapy as assessed by Blinded Independent Clinical Review (BICR) for the first-line treatment of patients with MSI-H/dMMR mCRC.
The study is ongoing to assess the other dual primary endpoint of PFS in patients receiving Opdivo plus Yervoy compared to Opdivo alone, as well as secondary endpoints.
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