FX.co ★ Bristol Myers Says Type II Variation Application For Opdivo + Yervoy Granted EMA Validation

Bristol Myers Squibb announced on Monday that their Type II variation application for using a combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for initial treatment in adult patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer has been validated by the European Medicines Agency (EMA). This validation by the EMA affirms that the submission is complete and initiates EMA's centralized review process.

The application is based on results from the CheckMate-8HW study. This study found that the combination of Opdivo and Yervoy demonstrated a significant and clinically meaningful improvement in progression-free survival (PFS), which was one of the dual primary endpoints. This combination was compared to the investigator's choice of chemotherapy, as reviewed independently and blindly for the initial treatment of patients bearing MSI-H or dMMR metastatic colorectal cancer.

Still underway, the study is also assessing the second dual primary endpoint; observing PFS in patients receiving Opdivo and Yervoy as compared to Opdivo alone along with various secondary endpoints.