Eisai announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for lenvatinib mesylate for the treatment of progressive radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC) and granted the NDA Priority Review status.
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 thought to be involved in tumor proliferation.
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Previously, the FDA had granted Orphan Drug designation to lenvatinib in various types of thyroid cancer. It is currently under investigation in thyroid, hepatocellular, endometrial, non-small cell lung cancer, and other solid tumor types.
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