The Food and Drug Administration has granted priority review designation to lenvatinib mesylate (lenvatinib) for the treatment of patients with progressive, radioactive iodine-refractory differentiated thyroid cancer.
The drug, marketed by Eisai, Inc., is an oral multiple receptor tyrosine kinase inhibitor with a unique binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors, in addition to other proangiogenic and oncogenic pathway-related tyrosine kinases thought to be involved in tumor proliferation.
The FDA's priority review designation shortens the time to complete a drug's review and aims to deliver a decision on marketing approval designation for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists within six months under the Prescription Drug User Fee Act (PDUFA).
Approval for lenvatinib will be based on data from the SELECT (Study of [E7080] Lenvatinib in Differentiated Cancer of the Thyroid) trial. That multicenter, randomized, double-blind, placebo-controlled Phase III study compared progression-free survival of patients with radioactive iodine-refractory differentiated thyroid cancer and radiographic evidence of disease progression within the prior 12 months, treated with once-daily, oral lenvatinib versus placebo. The study included 392 patients.