Eisai's Lenvatinib Receives FDA Priority Review for the Potential Treatment of Advanced Renal Cell Carcinoma in Combination with Everolimus

WOODCLIFF LAKE, N.J., Jan. 17, 2016 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (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.

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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.

The information in this release includes discussion of an investigational use for an FDA-approved product. It is not intended to convey conclusions about efficacy or safety. There is no guarantee that this investigational use will successfully gain FDA approval.

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About Renal Cell Carcinoma

Renal cell carcinoma (RCC), also known as renal cell cancer or renal cell adenocarcinoma, is the most common type of kidney cancer, representing about 90% of cases in the United States. Renal cell carcinoma occurs when malignant cells a­­re found in the lining of the tubules in the kidney. In 2015, there were approximately 61,560 new cases of kidney cancer and about 14,080 people will die from the disease. Approximately 16% of patients with RCC will have metastases at diagnosis and as many as 40% will demonstrate metastasis after primary surgical treatment for localized RCC. With a 5-year survival rate ranging from 5-12%, the prognosis for these patients is poor.

About Lenvatinib (Available as LENVIMA®)

LENVIMA® (lenvatinib) is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).

Lenvatinib, discovered and developed by Eisai, 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, tumor 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. Lenvatinib was approved under Priority Review designation for locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer by the FDA in February 2015. Eisai was granted Orphan Drug Designation (ODD) for lenvatinib in various types of thyroid cancer in the United States, Japan, and Europe.

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