By Tom Rosenthal
The FDA approved a new indication for lenvatinib (Lenvima, Eisai and Merck) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
Lenvatinib, a kinase inhibitor, works by blocking angiogenesis, which keeps tumors from growing.
The FDA said the new indication was granted on the basis of the REFLECT study, an international, multicenter, randomized trial conducted in 954 patients with previously untreated, metastatic or unresectable HCC.