FDA Accepts Lenvatinib Application for Advanced HCC

September 26, 2017 – The FDA has accepted a supplemental new drug application for lenvatinib (Lenvima) as a frontline systemic treatment for patients with advanced hepatocellular carcinoma (HCC), according to a statement from the company developing the therapy, Eisai. Under a standard review, the FDA will render a decision within 10 months. The application for lenvatinib was based on findings from the phase III REFLECT trial, in which overall survival (OS) was … (leggi tutto)