India, May 6 -- 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).
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