Novartis files RAD001 with EMEA

Novartis has announced that RAD001 (everolimus) has had its brand name – Afinitor – accepted by the European Medicines Agency (EMEA).

The company has also announced the filing or regulatory submissions for the compound in the EU, US and Switzerland as a treatment for advanced kidney cancer.

These applications follow the publication of clinical trial data in the Lancet showing that RAD001 more than doubles the time without tumour risk and reduces the risk of disease progression by 70 per cent.

Novartis said the compound has shown the potential to become the first once-daily orally-administered drug targeting the mTOR protein in this indication.

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.”

He added that the priority review status given to the compound by the US Food and Drug Administration brings the company one step closer to offering patients with this condition a promising new treatment option.

In May 2008, Novartis announced the publication of trial results of RAD001 which showed extended progression-free survival in patients regardless of risk status, age, gender or prior treatments.