Novartis' RAD001 gets US priority review

Swiss drug major Novartis says that RAD001 (everolimus) has been granted priority review by the US Food and Drug Administration. 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.

Novartis has also filed marketing authorization applications for RAD001 with the European Medicines Agency (EMEA) and the Swiss Agency for Therapeutic Products (Swissmedic). The proposed brand name for RAD001, Afinitor, has been accepted by the EMEA and is currently under review in the USA.

The regulatory submissions are based on data from the RECORD-1 (REnal Cell cancer treatment with Oral RAD001 given Daily) trial. Interim results from this study were published in The Lancet on July 23, and presented earlier this year at the annual meeting of the American Society of Clinical Oncology. The data show 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%.