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.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.