WASHINGTON — The FDA on Thursday approved the kinase inhibitor lenvatinib (Lenvima) for the first-line treatment of hepatocellular carcinoma (HCC) patients with unresectable disease.
Approval was based on the REFLECT study, a multicenter non-inferiority trial, which randomized 954 HCC patients 1:1 to either 8 mg or 12 mg oral lenvatinib (depending on the patient’s weight) versus 400 mg sorafenib twice daily until disease progression or unacceptable toxicity. The drug is approved at the 8 mg once-daily dose for patients <60 kg and at the 12 mg once-daily dose for those ≥60 kg.
“Unresectable hepatocellular carcinoma is an extremely difficult-to-treat cancer, with no new first-line systemic therapy options for more than a decade,” said Ghassan Abou-Alfa, MD, of Memorial Sloan Kettering Cancer Center in New York City, in a press release from drugmaker Eisai. “REFLECT is the first-ever positive phase III trial against an active comparator in unresectable HCC.”