FDA Approves Lenvatinib for Unresectable Hepatocellular Carcinoma

August 16, 2018 – Today, the U.S. Food and Drug Administration (FDA) approved lenvatinib capsules for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Approval was based on the international, multicenter, randomized, open-label, noninferiority REFLECT trial conducted in 954 patients with previously untreated, metastatic, or unresectable HCC. Patients were randomized 1:1 to receive lenvatinib (12 mg orally once daily for patients … (leggi tutto)