Bristol Myers Squibb Receives EMA Validation For Opdivo Plus Yervoy For Treatment Of HCC

(RTTNews) - Bristol-Myers Squibb Co. (BMY) announced on Friday that the European Medicines Agency has validated its Type II variation application for Opdivo or nivolumab in combination with Yervoy or ipilimumab as a potential first-line treatment for adult patients with unresectable or advanced hepatocellular carcinoma commonly known as HCC, who have not previously received systemic therapy.

This application is backed by results from the Phase 3 CheckMate -9DW trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to the investigator's choice of lenvatinib or sorafenib.

The company stated that this validation confirms that the submission is complete and triggers the European Medicines Agency's centralized review process.