Once-daily RCC therapy granted priority review

September 25, 2008

Novartis has announced that RAD001 (everolimus), an oral once-daily inhibitor of mTOR, for treatment of advanced kidney cancer, has been granted priority review by the FDA.

Novartis has announced that RAD001 (everolimus), an oral once-daily inhibitor of mTOR, has been granted priority review by the FDA. The designation is based on the drug's potential to become the first therapy to demonstrate significant benefit in patients with advanced kidney cancer after failure of standard treatment, the company said.

Regulatory submissions to the FDA and European regulatory agencies are based on data from the RECORD-1 trial, which showed that after failure of standard treatment in patients with advanced kidney cancer, RAD001 more than doubled time without tumor growth and reduced the risk of disease progression by 70%.

"Currently, patients with advanced kidney cancer who have experienced treatment failure with standard therapies have limited options," said Alessandro Riva, MD, of Novartis Oncology. "The priority review designation for RAD001 brings us one step closer to offering these patients a promising new therapy."