FDA Approves Differentiated Thyroid Cancer Treatment

The FDA today approved Eisai’s kinase inhibitor, lenvatinib (Lenvima), for the treatment of differentiated thyroid cancer (DTC) in patients whose disease progressed despite receiving radioactive iodine therapy.

Lenvima, which was reviewed under the FDA’s priority review program, was approved almost 2 months ahead of its scheduled goal date of April 14, 2015.

The agency based its nod on results from a placebo-controlled study in which Lenvima’s efficacy was evaluated in 392 patients with progressive, radioactive iodine-refractory DTC. The research team found that Lenvima-treated participants experienced a median of 18.3 progression-free months, compared with a median of 3.6 months for placebo recipients.

The researchers also discovered that 65% of Lenvima-treated patients experienced tumor reduction, compared with 2% of placebo recipients.

“The development of new therapies to assist patients with refractory disease is of high importance to the FDA,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “Today’s approval gives patients and healthcare professionals a new therapy to help slow the progression of DTC.”

The most common adverse events experienced by trial patients treated with Lenvima include hypertension, fatigue, diarrhea, arthralgia, myalgia, decreased appetite, decreased weight, nausea, stomatitis, headache, vomiting, proteinuria, abdominal pain, dysphonia, and palmar-plantar erythrodysesthesia syndrome.

Serious side effects associated with the use of Lenvima include cardiac failure, arterial thromboembolic events, hepatotoxicity, renal failure and impairment, gastrointestinal perforation, fistula formation, QT Interval Prolongation, hypocalcemia, Reversible Posterior Leukoencephalopathy Syndrome, serious hemorrhage, risks to an unborn child if a patient becomes pregnant during treatment, and impairing suppression of the production of thyroid-stimulating hormone.

In 2014, 62,980 Americans were diagnosed with thyroid cancer, of which DTC is the most common type, and 1890 died from the disease, according to National Cancer Institute estimates.