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The U.S. Food and Drug Administration (FDA) granted LENVIMA™ (lenvatinib) Breakthrough Therapy designation for 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, and the prognosis for patients with advanced disease is poor, with a 5-year survival rate ranging from 5-10%. The FDA granted full FDA approval in 2016.

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 promising drugs with preliminary clinical evidence that indicates the drug may demonstrate a substantial improvement over existing therapies.

LENVIMA™, was designated as a Breakthrough Therapy based on results of a Phase 2 clinical study involving 153 patients who were previously treated with a VEGF-targeted therapy and subsequently treated with the combination of LENVIMA™, and Afinitor.

About Renal Cell Carcinoma

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Each year in the United States, more than 61,000 people are diagnosed with kidney cancer. The most common type of kidney cancer is renal cell carcinoma (RCC), which starts in the lining of very small tubes (tubules) in the kidney. For people with advanced RCC (cancer that has spread to other parts of the body), targeted therapies can play an important role in treatment. 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.


LENVIMA is currently approved for the treatment of patients with radioactive iodine-refractory thyroid cancer. LENVIMA is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1-3. LENVIMA™ also inhibits other RTKs that have been implicated in cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4; the platelet derived growth factor receptor alpha (PDGFR?), KIT, and RET.

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