Eisai Inc. announced today the U.S. Food and Drug Administration (FDA) granted lenvatinib, the company's multiple receptor tyrosine kinase inhibitor, Breakthrough therapy designation for the investigational use in patients with advanced or metastatic renal cell carcinoma (RCC) who were previously treated with a vascular endothelial growth factor (VEGF)-targeted therapy. RCC is the most common type of kidney cancer, representing about 90% of cases in the U.S. Approximately 20-30% of patients with RCC will have metastatic (stage IV) disease at diagnosis and as many as 40% will demonstrate metastasis after primary surgical treatment for localized RCC. The prognosis for these patients is poor, with a 5-year survival rate ranging from 5-10%.

"We are excited and honored that the FDA has granted Breakthrough Therapy designation to lenvatinib for patients with metastatic renal cell carcinoma," said Kenichi Nomoto, Ph.D., President, Oncology Product Creation Unit at Eisai Inc. "We look forward to working closely with the FDA to expedite this clinical program and hope to offer an important additional treatment option to patients in need."

Lenvatinib, marketed under the brand name Lenvima, 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 metastatic renal cell carcinoma.

The FDA breakthrough therapy designation was established in 2012 to address unmet medical needs in the treatment of serious or life-threatening conditions. This designation is intended to expedite the development and review of drugs with preliminary clinical evidence that indicates the drug, alone or in combination, may demonstrate a substantial improvement over existing therapies and to help ensure patients have access to them as soon as possible.

For more details, go to: http://www.prnewswire.com/news-releases/fda-grants-breakthrough-therapy-designation-to-eisais-lenvatinib-for-the-potential-treatment-of-metastatic-renal-cell-carcinoma-300119511.html