Supplemental NDA of Opdivo – Yervoy Combo submitted in Japan to Expand the Use for Unresectable HCC
“This application is related to the additional indication for a partial change in approved items of the manufacturing and marketing approval in Japan. This application is based on the results from interim analysis of the CheckMate -9DW study, a global multi-center Phase 3 clinical study (CA209-9DW: ONO-4538-92), evaluating Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib monotherapy for patients with unresectable HCC who have not received prior systemic therapy. In this study, Opdivo plus Yervoy met its primary endpoint of overall survival (OS), demonstrating a statistically significant and clinically meaningful improvement in OS compared to lenvatinib or sorafenib monotherapy. The safety profile of Opdivo plus Yervoy was consistent with previously reported data, with no new safety signals identified.”
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