Eisai and Merck Annouces the US FDA Approval of Lenvima for Unresectable 1L Hepatocellular Carcinoma (HCC)
Shots:
- Approval is based on positive results of Ph III REFLECT study showing improved OS- PFS and ORR
- REFLECT results (Lenvima vs Sorafenib): mOS (13.6 vs 12.3 mos)- mPFS (7.3 vs 3.6 mos); ORR (41% vs 12%) with AE ≥20% patients & SAEs ≥2%
- Lenvima has been approved in Japan in H1’18 for HCC and was first approved in Feb’15 for thyroid cancer
Ref: Eisai | Image: Merck
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