The U.S. Food and Drug Administration (FDA) has given Priority Review designation to the New Drug Application for lenvatinib mesylate as a treatment for progressive radioactive iodine–refractory differentiated thyroid cancer. 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 receptors, in addition to other proangiogenic and oncogenic pathway-related tyrosine kinases thought to be involved in tumor proliferation.
Priority Review designation is granted when the FDA believes the drug has the potential to provide “a significant improvement in safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition.”
Lenvatinib was previously granted Orphan Drug designation for use in various types of thyroid cancer in the United States, Japan, and Europe. It is currently under investigation in thyroid, hepatocellular, endometrial, non–small cell lung cancer, and other solid tumor types. ■