FDA Approves Lenvima for Frontline Liver Cancer Treatment

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

The agency based its approval on the international, multicenter, randomized, non-inferiority phase 3 REFLECT trial, which included 954 patients with previously untreated, metastatic or unresectable HCC. Patients were randomized to receive either oral Lenvima or Nexavar (sorafenib).

Trial results showed that Lenvima — a multikinase inhibitor that prevents cancerous tumors from forming the blood vessels and accessing proteins that they need to grow and spread – was neither inferior nor statistically superior to Nexavar when it came to median overall survival rates (13.6 months vs. 12.3 months).

However, patients treated with Lenvima showed significant improvements in progression-free survival compared with those given Nexavar (7.3 months vs. 3.6 months). The Lenvima arm also demonstrated superior objective response rates (24.1 percent vs. 9.2 percent), including a 1.3 percent complete response rate compared with 0.4 percent in the Nexavar arm.

In addition, the median duration of response was 5.7 months with Lenvima and 3.7 months for Nexavar.

The most common side effects associated with Lenvima included hypertension, fatigue, diarrhea, decreased appetite, arthralgia/myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism and nausea.

The FDA recommended that drug dosage be based on body weight: 12 mg daily for patients who weigh at least 60 kg or 8 mg daily for patients who weigh less than 60 kg.

The drug was previously approved for patient with locally recurrent or metastatic progressive, radioactive iodine-refractory differentiated thyroid cancer and in combination with everolimus for advanced renal cell carcinoma.