The US Food and Drug Administration (FDA) has granted priority review to Novartis’ RAD001 (everolimus) on the basis of the drug’s potential to benefit patients suffering from advanced kidney cancer who showed no improvement after the standard treatment. The data collected from a trial shows that RAD001 curbs tumor growth, reducing the risk of disease progression by 70%.Novartis has already applied for marketing authorization for RAD001 with the European Medicines Agency (EMEA) and the Swiss Agency for Therapeutic Products (Swissmedic). EMEA has even accepted the proposed brand name for RAD001, Afinitor®.

Novartis Inc has initiated the Phase III trial for its non-small cell lung cancer drug, ASA404, designed to selectively reduce blood supply to tumors. The randomized, double-blind, placebo-controlled, multicenter study, named ATTRACT-1, is designed to evaluate ASA404 in combination with paclitaxel and carboplatin as first-line treatment for locally advanced or metastatic non-small cell lung cancer.

Interim results from a major Phase III clinical trial of everolimus (RAD001) showed that the study met its primary endpoint. The interim results indicated that the investigational drug exhibited significantly higher progression-free survival in patients with advanced kidney cancer as compared to placebo. The Phase III clinical trial has been halted and investigators will now offer everolimus to trial subjects who are still taking placebo. Novartis has said that the trial results will be submitted for presentation at the ASCO (American Society of Clinical Oncology) annual meeting in May.