The U.S. health regulating agency (FDA) has granted a “priority review” status – meaning the drug’s protocol should be reviewed within six months instead of the normal ten months or more – for Novartis AG´s experimental cancer treatment RAD001 (everolimus).

The Basel-based company reported this designation was based on the successful trials with RAD001 – presented within the framework of the American Society of Clinical Oncology (ASCO) meeting last May - showing its significant benefit for patients with advanced kidney cancer after standard treatment had failed.

The once-a-day pill works by blocking a protein known as mTOR, disrupting the growth, division and metabolism of cancer cells. In the trial known as RECORD-1 that included 400 patients, 272 were given RAD-001 and 138 were given placebo.

After six months, tumors had not grown or spread in 26 percent of patients who got RAD-001, compared to 2 percent of the placebo group. On average, patients on RAD-001 enjoyed four months of so-called progression-free survival compared to just under two months for those who got the placebo.

The results of the study showed that after the failure of standard treatment in patients with advanced kidney cancer, RAD001 more than doubled time without tumor growth and declined the risk of disease progression by 70 percent.

RAD-001 is also being tested in other cancers including lymphoma and neuroendocrine tumors, and for breast tumor shrinkage in combination with other drugs.

Novartis stated that it filed marketing authorization applications for RAD001 with the European Medicines Agency (EMEA) and the Swiss Agency for Therapeutic Products.

The proposed brand name for RAD001 is Afinitor, which has been accepted by the EMEA and is presently under review in the U.S.

If approved, RAD-0001/Afinitor would compete with Wyeth´s Torisel (temsirolimus), approved by the FDA and EMEA in 2007. In the first half of this year, Torisel had earnings for some $ 54 million dollars, of which $ 40 million were U.S. sales.