Eisai’s lenvatinib receives FDA priority review

18 January 2016  •  Author: Victoria White

The US Food and Drug Administration (FDA) has accepted for Priority Review Eisai’s supplemental New Drug Application (sNDA) for lenvatinib for the potential treatment of patients with renal cell carcinoma.


Specifically, the sNDA is for lenvatinib in 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.

Lenvatinib could potentially be the first tyrosine kinase inhibitor for RCC

Commenting on the announcement, Kenichi Nomoto, Ph.D., President, Oncology Product Creation Unit, Eisai Product Creation Systems, said, “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. 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 is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1-3. Lenvatinib also inhibits other RTKs that have been implicated in pathogenic angiogenesis, tumour growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4; the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET.

Sold under the brand name Lenvima, the therapy 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.

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