Eisai has received approval from the US Food and Drug Administration (FDA) for a new indication of its anticancer agent, Lenvima (lenvatinib mesylate), as a treatment for advanced renal cell carcinoma.

The approval expands the use of Lenvima to include its use in combination with everolimus for patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy.

Lenvima was initially indicated for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer in the US.

"The FDA approval is based on the Phase II clinical study, which evaluated the safety and efficacy of Lenvima."

It has been approved to treat thyroid cancer in more than 40 countries, including Japan, in Europe, South Korea, and Canada.

Lenvima is an orally administered multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor receptors and fibroblast-growth factor receptors.

The FDA approval is based on the Phase II clinical study (Study 205), which evaluated the safety and efficacy of Lenvima alone, and in combination with everolimus.

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The multicentre, randomised, open-label study evaluated the efficacy of lenvatinib mesylate in patients with unresectable advanced or metastatic renal cell carcinoma.

Renal cell carcinoma or kidney cancer is a disease in which malignant cells are found in the lining of tubules (very small tubes) in the kidney.

Eisai said that it is conducting clinical studies of Lenvima in several other tumour types, including a Phase III study of the agent in hepatocellular carcinoma.

Image: High magnification micrograph of a clear cell renal cell carcinoma. Photo: courtesy of Nephron.