Dr. Bekaii-Saab Discusses the FDA Approval of Lenvatinib in HCC

Tanios Bekaii-Saab, MD, professor of medicine, Mayo Clinic, discusses the FDA approval of lenvatinib (Lenvima) as a frontline systemic treatment for patients with advanced hepatocellular carcinoma (HCC).

This approval was based on data from the phase III REFLECT trial, in which the multikinase inhibitor lenvatinib showed noninferiority to sorafenib (Nexavar). The median overall survival was 13.6 months with lenvatinib compared with 12.3 months for the first-line standard of care sorafenib (HR, 0.92; 95% CI, 0.79-1.06). The median progression-free survival was 7.4 versus 3.7 months for lenvatinib and sorafenib, respectively (HR, 0.66; 95% CI: 0.57-0.77; P <.0001). Time-to-progression was 8.9 months for lenvatinib compared with 3.7 months for sorafenib (HR, 0.63; 95% CI, 0.53-0.73; P <.0001).

Lenvatinib will now be available as an option for the frontline treatment of patients with unresectable HCC.