A new medication, lenvantinib, for patients with advanced hepatocarcinoma.
A supplemental new drug application for lenvatinib (Lenvima) as a frontline systemic treatment for patients with advanced hepatocellular carcinoma (HCC) has been accepted by the FDA, acccording to a statement from Eisai, the company developing the therapy.
Findings from the phase III REFLECT trial, on which the application for lenvatinib was based, showed overall survival (OS) was noninferior for lenvatinib versus sorafenib. Median OS with lenvatinib was 13.6 versus 12.3 months for sorafenib (HR, 0.92; 95% CI, 0.79-1.06). Lenvatinib was also associated with improvements in progression-free survival (PFS), time to progression (TTP) and objective response rate (ORR) compared with sorafenib.
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