The acceptance of the supplemental Biologics License Application is based on results from the Phase 3 CheckMate-9DW trial, which demonstrated that the combination of Opdivo and Yervoy significantly improved overall survival in patients with hepatocellular carcinoma.
FDA Approves Bristol-Myers Squibb’s sBLA for Opdivo Plus Yervoy Combination Therapy for Hepatocellular Carcinoma
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