Eisai and Merck Annouces the US FDA Approval of Lenvima for Unresectable 1L Hepatocellular Carcinoma (HCC)
Eisai’s and Merck Announces EU’s Marketing Approval of Lenvima (lenvatinib mesylate) for Hepatocellular carcinoma
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