FDA to consider Lenvima as potential first-line liver cancer therapy

An application from Tokyo’s Eisai to add an additional indication to anticancer agent Lenvima (lenvatinib mesylate) has been accepted by the US Food and Drug Administration.

The agency will consider broadening the label to include treatment of hepatocellular carcinoma in the first-line setting. Lenvima has been given orphan drug status in this indication.

The application is based on the results of the REFLECT study, which met its primary endpoint and demonstrated non-inferior overall survival in comparison with Nexavar (sorafenib).

The company says adverse events were consistent with the known side-effect profile of Lenvima.