The U.S. Food and Drug Administration has approved Eisai Co.’s Lenvima (lenvatinib) for the treatment of patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed on or after radioactive iodine therapy. The approval comes just one day after results from the phase III SELECT study were published in the New England Journal of Medicine.
“The development of new therapies to assist patients with refractory disease is of high importance to the FDA,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval gives patients and healthcare professionals a new therapy to help slow the progression of DTC.”
The SELECT study was a multicenter, double-blind, placebo-controlled phase III study that enrolled 392 patients with progressive RR-DTC. Patients were randomly assigned 2:1 to receive either lenvatinib 24mg orally daily in 28-day cycles or placebo.
Results showed a median progression-free survival of 18.3 months in the lenvatinib group versus 3.6 months in the placebo group (HR = 0.21; 95% CI: 0.14 – 0.31; P < 0.001). In addition, the response rates were 64.8% and 1.5% for the lenvatinib and placebo groups, respectively (P < 0.001).
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In regard to safety, the most common lenvatinib-related adverse events were hypertension, diarrhea, decreased appetite, weight loss, and nausea, all occurring in more than 40% of patients. Of note, 78.% of patients had a dose reduction and 14.2% discontinued treatment due to toxicities. Lenvatinib treatment was associated with six deaths.
Lenvatinib is a novel investigational oral multiple receptor tyrosine kinase inhibitor that selectively inhibits VEGFR, FGFR, RET, KIT, and PDGFR.
Differentiated thyroid cancer is the most common form of thyroid cancer, but some are radioiodine-refractory and cannot be easily cured with surgery and radioactive iodine, thereby presenting a place in therapy for lenvatinib.