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FDA Approves Lenvatinib for Unresectable Hepatocellular Carcinoma

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Today, the U.S. Food and Drug Administration (FDA) approved lenvatinib capsules (Lenvima) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

REFLECT Trial

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 with a baseline body weight of ≥ 60 kg and 8 mg orally once daily for patients with a baseline body weight of < 60 kg) or sorafenib (Nexavar; 400 mg orally twice daily). Treatment continued until radiologic disease progression or unacceptable toxicity.

REFLECT demonstrated that lenvatinib was noninferior but not statistically superior to sorafenib for overall survival (OS) (hazard ratio [HR] = 0.92; 95% confidence interval [CI] = 0.79–1.06). Median OS in the lenvatinib arm was 13.6 months and 12.3 months in the sorafenib arm. REFLECT also demonstrated a statistically significant improvement in progression-free survival (PFS) with lenvatinib as compared to sorafenib. Median PFS was 7.3 months in the lenvatinib arm and 3.6 months in the sorafenib arm (HR = 0.64; 95% CI = 0.55–0.75; P < .001) per modified RECIST for HCC (mRECIST); findings were similar according to RECIST 1.1. The overall response rate was higher for the lenvatinib arm as compared to sorafenib (41% vs 12% per mRECIST and 19% vs 7% per RECIST 1.1).

The most common adverse reactions observed in the lenvatinib-treated patients with HCC (≥ 20%) in order of decreasing frequency 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 dosage for patients with HCC is 12 mg orally once daily in patients 60 kg or greater actual body weight or 8 mg orally once daily in patients less than 60 kg actual body weight.

Full prescribing information for lenvatinib can be found at https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206947s007lbl.pdf.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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