Bristol Myers announced that the European Medicines Agency, or EMA, validated its Type II variation application for Opdivo plus Yervoy as a potential first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma – HCC – who have not received prior systemic therapy. The application was based on results from the Phase 3 CheckMate -9DW trial and validation of the application confirms the submission is complete and begins the EMA’s centralized procedure review. In the Phase 3 trial, Opdivo plus Yervoy demonstrated statistically significant and clinically meaningful improvement in overall survival vs. investigator’s choice of lenvatinib or sorafenib, which showed the clinical benefit of the combination treatment option when provided in the first-line setting. The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data.
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