Novartis announced that RAD001 (everolimus) has been granted priority review by the US Food and Drug Administration (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.
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 US.
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, 2008, 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 tumour growth and reduced the risk of disease progression by 70 per cent.
"Currently, patients with advanced kidney cancer who have experienced treatment failure with standard therapies have limited options," said Alessandro Riva, vice president & global head of Development, Novartis Oncology. "The priority review designation for RAD001 brings us one step closer to offering these patients a promising new therapy."
FDA priority review status is granted to therapies that could potentially fill a currently unmet medical need and accelerates the standard review timing from ten to six months.
RAD001, an oral once-daily inhibitor of mTOR, is an investigational drug being studied in multiple tumour types.