The US Food and Drug Administration has accepted for priority review Eisai Inc.’s supplemental new drug application (sNDA) for lenvatinib for the potential treatment of patients with 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 investigational indication.

An application for a drug will receive priority review by the FDA if it is a drug that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. It cuts the review time from the standard review time of 10 months to six months.

Breakthrough therapy designation is reserved for drugs with preliminary clinical evidence that indicates the drug, alone or in combination, may demonstrate a substantial improvement over existing therapies for the treatment of a serious condition.

Lenvatinib, discovered and developed by Eisai, is a multiple receptor tyrosine kinase inhibitor. Sold under the brand name Lenvima, lenvatinib is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.

Source: Eisai