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Lenvima Now Approved for Unresectable Hepatocellular Carcinoma

Web Exclusives - FDA Approvals

On August 16, 2018, the FDA approved lenvatinib (Lenvima; Eisai) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

This approval was based on the multicenter, randomized, open-label, noninferiority REFLECT clinical trial of 954 patients with untreated metastatic or unresectable HCC. Patients were randomized in a 1:1 ratio to lenvatinib or to sorafenib (Nex­avar) until radiologic disease progression or unacceptable toxicity.

The median overall survival was 13.6 months with lenvatinib versus 12.3 months with sorafenib (hazard ratio, 0.92; 95% confidence interval, 0.79-1.06).

The median progression-free survival with lenvatinib was 7.3 months versus 3.6 months with sorafenib (P <.001). The overall response rate was 41% with lenvatinib versus 12% with sorafenib.

The most common (≥20%) adverse events with lenvatinib were hypertension, fatigue, diarrhea, decreased appetite, arthralgia or myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism, and nausea.

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Last modified: February 19, 2019