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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April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.