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news.Novartis has announced that RAD001 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.
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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 trial. Interim results from this study 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%.
RAD001, an oral once-daily inhibitor of mTOR, is an investigational drug being studied in multiple tumor types. If approved, RAD001 will become the first oral, once-daily therapy that targets mTOR to treat advanced kidney cancer, said Novartis.
In addition to renal cell carcinoma, RAD001 is being evaluated as a single agent or in combination with existing therapies in neuroendocrine tumors, lymphoma, breast, gastric, lung and other cancers, as well as tuberous sclerosis.
Alessandro Riva, vice president and global head of development at Novartis Oncology, said: “Currently, patients with advanced kidney cancer who have experienced treatment failure with standard therapies have limited options. The priority review designation for RAD001 brings us one step closer to offering these patients a promising new therapy.”