Human healthcare company Eisai Inc and Merck (NYSE:MRK) onThursday jointly announced the receipt of the US Food and Drug Administration's (FDA) approval for the kinase inhibitor LENVIMA (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.

This the second US FDA's approval under Eisai-Merck global collaboration to co-develop and co-commercialise LENVIMA, following Japan in March 2018.

The US FDA's approval was based on Eisai's REFLECT (Study 304), a large phase 3, randomised, multi-centre, open-label trial conducted to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in patients with unresectable hepatocellular carcinoma (HCC). Patients at 154 trial sites in 20 countries were randomised to receive lenvatinib 12 mg or 8 mg once a day depending on body weight (≥60 kg or