The FDA approved a new indication for the kinase inhibitor lenvatinib (Lenvima, Eisai and Merck) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
The new indication was granted on the basis of the REFLECT study (NCT01761266), an international, multicenter, randomized non-inferiority trial conducted in 954 patients with previously untreated, metastatic or unresectable HCC.