FDA approves Eisai's Lenvima for first-line HCC

FDA approved Lenvima lenvatinib mesylate from Eisai Co. Ltd. (Tokyo:4523) as first-line treatment of unresectable hepatocellular carcinoma (HCC).

The approval was based on data from the Phase III REFLECT trial in patients with previously untreated, metastatic or unresectable HCC in which Lenvima met the primary endpoint of non-inferiority to Nexavar sorafenib in median overall survival (OS) (13.6 vs. 12.3 months). Lenvima also met the secondary endpoint of improving median progression-free survival (PFS) vs. Nexavar (7.3 vs. 3.6 months, p<0.001)...