Wyeth Pharmaceuticals, a division of Wyeth, announced today that the US Food and Drug Administration (FDA) has accepted the file and granted priority review status to the company's New Drug Application (NDA) for the investigational drug Torisel (temsirolimus).

Wyeth Pharmaceuticals is seeking an indication for Torisel for the treatment of advanced renal cell carcinoma (RCC). A priority designation can be given to an NDA for a drug that, if approved, would be a significant improvement compared with existing treatments.

The FDA previously granted fast track designation and orphan drug status for investigational temsirolimus for the treatment of advanced RCC.

Torisel is the first mTOR (mammalian target of rapamycin) inhibitor to be filed for approval for the treatment of a cancer. It is an investigational drug that specifically inhibits the mTOR kinase, a protein that regulates cell proliferation, cell growth and cell survival.

"Renal cell carcinoma continues to be an extremely difficult-to-treat form of cancer, and there continues to be a need for new therapies. Torisel has demonstrated its potential to help meet that important medical need," says Lee F. Allen, M.D., Ph.D., Vice President of Oncology Clinical Research at Wyeth.

The registration dossier contains interim data from a three-arm, Phase 3 clinical trial of 626 patients who had received no prior systemic therapy. The results showed that Torisel significantly increased overall survival by 49 percent in patients with advanced RCC compared with interferon-alpha, a treatment for advanced RCC.

In the United States, Torisel will be available prior to FDA approval through an Expanded Access Program (EAP).