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Eisai’s Lenvatinib Gains Priority Review

January 18, 2016

For the potential treatment of unresectable advanced or metastatic renal cell carcinoma

Eisai’s sNDA for lenvatinib has been accepted for Priority Review by the FDA for the potential treatment of unresectable advanced or metastatic renal cell carcinoma (RCC) in combination with everolimus following one prior vascular endothelial growth factor (VEGF)-targeted therapy. The FDA had previously granted lenvatinib Breakthrough Therapy designation for this indication.
 
Priority Review is intended for drugs that treat serious conditions and, if approved, would provide a significant improvement in safety or effectiveness. The prognosis for patients with advanced renal cell carcinoma is poor and additional treatment options are needed.
 
Lenvatinib is a multiple receptor tyrosine kinase inhibitor sold as LENVIMA, and is indicated for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).
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