FDA speeds up review of kidney cancer therapy

September 11, 2008

Drug may become the first approved once-daily therapy to treat advanced kidney cancer.

The Food and Drug Administration has granted priority review status to Novartis' RAD001 (everolimus), which may become the first approved once-daily therapy to treat advanced kidney cancer.

A recent study, presented at the American Society of Clinical Oncology and published in The Lancet, showed RAD001 more than doubled time without tumor growth and reduced the risk of disease progression by 70 percent. "Currently, patients with advanced kidney cancer who have experienced treatment failure with standard therapies have limited options," Alessandro Riva, Novartis' vice president and global head of development, said. "The priority review designation for RAD001 brings us one step closer to offering these patients a promising new therapy."

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