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FDA Approves Lenvatinib (Lenvima) for Thyroid Cancer

Treatment improves survival versus placebo in pivotal study

The FDA has granted approval to lenvatinib (Lenvima, Eisai Inc) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease has progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease).

DTC is the most common type of thyroid cancer. The National Cancer Institute estimates that 62,980 Americans were diagnosed with thyroid cancer and that 1,890 died from the disease in 2014.

Lenvatinib is a kinase inhibitor that works by blocking certain proteins from helping cancer cells grow and divide.

Lenvatinib was evaluated under the FDA’s priority review program, which provides expedited reviews of drugs that, if approved, would provide significant improvement in safety or effectiveness in the treatment of serious conditions. The drug was approved approximately 2 months ahead of the Prescription Drug User Fee Act (PDUFA) goal date of April 14, 2015, the date when the agency was scheduled to complete its review of the application.

The efficacy of lenvatinib was demonstrated in 392 patients with progressive, radioactive iodine-refractory DTC who were randomly assigned to receive either lenvatinib or placebo. The results showed that lenvatinib-treated patients lived a median of 18.3 months without their disease progressing (i.e., progression-free survival) compared with a median period of 3.6 months for patients who received placebo. In addition, 65% of patients treated with lenvatinib demonstrated reductions in tumor size compared with 2% the placebo-treated patients.

The most common adverse effects of lenvatinib included hypertension, fatigue, diarrhea, arthralgia, myalgia, decreased appetite, decreased weight, nausea, stomatitis, headache, vomiting, proteinuria, palmar–plantar erythrodysesthesia syndrome, abdominal pain, and dysphonia.

In addition, lenvatinib may cause serious adverse effects, including cardiac failure, arterial thromboembolic events, hepatotoxicity, renal failure and impairment, gastrointestinal perforation or fistula, QT-interval prolongation, hypocalcemia, reversible posterior leukoencephalopathy syndrome, and serious hemorrhage.

Sources: FDA; February 13, 2015; and NEJM; February 12, 2015.


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