Eisai gets BTD for Lenvatinib

WOODCLIFF LAKE, N.J.July 28, 2015 /PRNewswire/ — 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.

Lenvatinib was designated as a Breakthrough Therapy based on results of a Phase 2 open-label, multicenter study involving 153 patients who were previously treated with a VEGF-targeted therapy and randomized 1:1:1 to receive lenvatinib and everolimus (18+5 mg once a day), lenvatinib (24 mg once a day) or everolimus (10 mg once a day). Nearly all patients (99%) had received one prior VEGF-targeted therapy, 1% had received two prior VEGF-targeted therapies, and 18% had received prior immunotherapy treatment. The results of this study were presented in an oral presentation at the 2015 American Society of Clinical Oncology (ASCO) annual meeting.

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

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 will be approximately 61,560 new cases of kidney cancer and about 14,080 people will die from the disease. Approximately 20-30% 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 5-10%, the prognosis for these patients is poor.

About Lenvatinib (Available as LENVIMA™)
LENVIMA (lenvatinib) is approved for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). LENVIMA (lenvatinib) has not been approved for patients with metastatic renal cell carcinoma.

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. LENVIMA (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 StatesJapan, and Europe.