Eisai has announced that the FDA has accepted for Priority Review the 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. 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.

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.

More than 61,000 new cases of kidney cancer will be diagnosed in the U.S. this year. Approximately 16% of patients with renal cell carcinoma will have metastases at diagnosis and as many as 40% will develop metastasis after primary surgical treatment for localized RCC. The prognosis for these patients with advanced RCC is poor and additional treatment options are needed.

"With the FDA's acceptance of this supplemental application, we are one step closer to potentially providing the first tyrosine kinase and mTOR inhibitor combination therapy to patients with unresectable advanced or metastatic renal cell carcinoma," said Kenichi Nomoto, Ph.D., president, Oncology Product Creation Unit, Eisai Product Creation Systems. "We look forward to working with the FDA over the coming months as it considers this potential new option for patients with advanced RCC."

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 (DTC). Lenvatinib is not indicated for patients with unresectable advanced or metastatic renal cell carcinoma.