The Food and Drug Administration has approved the kinase inhibitor lenvatinib (Lenvima) for the treatment of differentiated thyroid cancer, the agency announced Feb. 13. The drug is approved for use in patients in whom disease progressed despite receiving radioactive iodine therapy.

A trial of 392 patients with progressive, radioactive iodine–refractory differentiated thyroid cancer (DTC) found a median progression-free survival time of 18.3 months in participants treated with Lenvima, compared with a median of 3.6 months in those who received a placebo, the FDA said in a statement . In addition, 65% of lenvatinib-treated patients saw a reduction in tumor size, compared with just 2% of patients who received placebo.

DTC is the most common type of thyroid cancer. The National Cancer Institute has estimated that nearly 63,000 Americans were diagnosed with thyroid cancer, and nearly 1,900 died from the disease in 2014, the FDA said.

Lenvima was approved early upon expedited review under the FDA’s priority review program, which allows for the accelerated evaluation of promising drugs that would significantly benefit patients with serious illness.

Common side effects from the drug included hypertension, fatigue, diarrhea, joint and muscle pain, decreased appetite, weight loss, and nausea, among others.

Lenvima is marketed by Eisai, based in Woodcliff Lake, N.J.


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