Posted by Michael Wonder on 27 Sep 2017
Application for additional indication of Lenvima for hepatocellular carcinoma accepted for review by U.S. FDA
27 September 2017 - Eisai has announced that the application submitted for an additional indication of its in-house discovered and developed anti-cancer agent Lenvima (generic name: lenvatinib mesylate) for the treatment of hepatocellular carcinoma has been accepted for review by the U.S. FDA.
Lenvatinib for the treatment of hepatocellular carcinona (HCC) is designated as an orphan drug by the FDA.
This application is based on the results of the REFLECT study (Study 304), a multicenter, open-label, randomized, global Phase III trial comparing the efficacy and safety of Lenvima versus sorafenib, a standard treatment for HCC, as a first-line treatment for patients with unresectable HCC.
