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.
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