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news.The US Food and Drug Administration (FDA) has accepted to review Eisai's new drug application (NDA) and has granted Priority Review status for its in-house developed agent lenvatinib mesylate (lenvatinib) to treat progressive radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC).
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Discovered and developed by Eisai, lenvatinib 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.
The approval was based on a multicenter, randomized, double-blind, placebo-controlled Phase III trial called SELECT, which compared the progression-free survival of patients with RAI-refractory DTC and radiographic evidence of disease progression within the prior 12 months, treated with once-daily, oral lenvatinib (24mg) versus placebo.
About 392 patients in 117 sites in Europe, North and South America and Asia were enrolled in the trial that was conducted by Eisai in collaboration with the SFJ Pharmaceuticals Group.
In June, the company had submitted marketing authorization applications for approval of lenvatinib in Japan for the indication of thyroid cancer.
Applications for the approval of lenvatinib were also submitted in June 2014 in Europe and the US for the indication of progressive, radioiodine-refractory differentiated thyroid cancer.
The company said that lenvatinib secured orphan drug designation for thyroid cancer in Japan, Europe and the US.