Lenvatinib NDA Under Review for RAI-Refractory Differentiated Thyroid Cancer
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.
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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