Approval was based on a noninferiority trial of 954 patients with previously untreated, metastatic or unresectable HCC, comparing treatment with lenvatinib to sorafenib, according to an FDA statement.
Lenvatinib was found noninferior but not statistically superior to sorafenib for overall survival (hazard ratio, 0.92; 95% confidence interval, 0.79-1.06). Median overall survival was 13.6 months for patients in the lenvatinib arm, compared with 12.3 months for patients in the sorafenib arm.
The most common adverse reactions with lenvatinib were hypertension, fatigue, diarrhea, decreased appetite, arthralgia/myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism, and nausea.
The recommended lenvatinib dosages are 12 mg orally once daily in patients weighing 60 kg or greater actual body weight or 8 mg orally once daily in patients weighing less than 60 kg actual body weight, the FDA said.
Lenvatinib is marketed as Lenvima by Eisai.