Eisai granted additional indication for Lenvima in renal cell carcinoma

pharmafile | May 16, 2016 | News story | Sales and Marketing Eisai, additional indication, renal cell carcinoma 

Eisai has announced that it has received approval from the US Food and Drug Administration (FDA) for an additional indication for oncology drug Lenvima (lenvatinib mesylate). It is now approved, in combination with Afinitor (everolimus), for the treatment of patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy.

The Japanese company indicates that this is the only combination regimen to significantly prolong progression-free survival when compared with a standard of care in patients with advanced renal cell carcinoma following prior anti-angiogenic therapy.

Granted both priority review by the FDA and accelerated assessment from the European Medicines Agency (EMA), Lenvima was submitted for approval to the EMA in combination with Novartis’s Afinitor in January.

Renal cell carcinoma accounts for more than 90% of all malignant cancers of the kidney. For advanced forms of the disease, the long term survival rate is poor. More than 58,000 patients are diagnosed with some form of kidney cancer in the US each year.

Eisai is conducting clinical trials of Lenvima in several other tumour types, including a late stage Phase III trial of the drug in hepatocellular carcinoma.

Sean Murray

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