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FDA accepts Priority Review for Potential Renal Cell Carcinoma Treatment

January 27, 2016


Eisai Inc., after submitting the New Drug Application for , announced that the FDA accepted the drug for Priority Review. Lenvatinib has the potential to treat patients with unresectable advanced or metastatic renal cell carcinoma (RCC).

The drug had previously been designated by the FDA as a Breakthrough Therapy drug, which is a status reserved for treatments that show a significant therapeutic improvement over already-existing therapies. The new Priority Review designation is applied to drugs that treat serious conditions and would have an impactful significance in safety or effectiveness.

Renal Cell Carcinoma

Renal cell carcinoma (RCC), also known as renal cell adenocarcinoma, occurs when malignant cells are found in the kidney’s tubules lining. In 2015, there were 61,560 new cases reported in the U.S., with 14,080 fatalities. It is the most common of kidney cancers, accounting for 90% of all kidney cancers in the U.S. The 5-year survival rate has a poor prognosis of 5-12%, with 40% of RCC patients having metastasized tumors after primary treatment. 16% of patients will already have metastasized tumors at the first diagnosis alone.

Regarding the Priority Review designation, Kenichi Nomoto, Ph.D., President of the Oncology Product Creation Unit at 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 as a Treatment for Renal Cell Carcinoma and Thyroid Cancer

Developed by Eisai, lenvatinib is a multiple receptor tyrosine kinase inhibitor and is currently sold under the name LENVIMA® to treat patients with locally recurrent or metastatic, progressive differentiated thyroid cancer (DTC). Eisai now aims to investigate lenvatinib’s usefulness in patients with unresectable advanced/metastatic renal cell carcinoma as well.

Lenvatinib inhibits other receptor tyrosine kinases that have been linked to pathogenic angiogenesis, tumor growth and cancer progression, including fibroblast growth factor (FGF) and the platelet-derived growth factor receptor alpha (PDGFRα).

For the specific purpose of treatment against various types of thyroid cancer, lenvantinib was formerly approved through the Orphan Drug Designation and under Priority Review designation by the FDA in February of 2015.

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