Shots:
- The EC has approved Opdivo + Yervoy as 1L therapy to treat inoperable or advanced HCC adult pts in 30 EEA states; sBLA under the US FDA’s priority review (PDUFA: Apr 21, 2025)
- Approval was based on P-III (CheckMate-9DW) trial assessing Opdivo (1mg/kg, Q3W) + Yervoy (3mg/kg, Q3W), followed by Opdivo alone (480mg, Q4W) vs lenvatinib/sorafenib in 668 pts with advanced HCC who had not received prior systemic therapy. In the comparator arm, 85% received lenvatinib, while 15% received sorafenib
- Study showed consistent OS (1EP) benefits across all subgroups, with mOS of 23.7 vs 20.6mos. & ORR of 36.1% vs 13.2%
Ref: Businesswire | Image: BMS
Related News:- BMS Reports P-III (CheckMate-816) Trial Data of Opdivo as a Neoadjuvant Treatment of Resectable NSCLC
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