Posted by Michael Wonder on 17 Aug 2018
Eisai and Merck announce FDA approval of Lenvima (lenvatinib) capsules for first-line treatment of unresectable hepatocellular carcinoma
16 August 2018 - Approval was based on REFLECT, the first-ever positive Phase 3 trial against an active comparator in previously untreated patients with unresectable HCC.
Eisai Inc. and Merck announced today that the U.S. FDA approved the kinase inhibitor Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
This approval was based on results from REFLECT (Study 304), where Lenvima demonstrated a proven treatment effect on overall survival by statistical confirmation of non-inferiority, as well as statistically significant superiority and clinically meaningful improvements in progression-free survival and objective response rate when compared with sorafenib in patients with previously untreated unresectable HCC.
