FDA GRANTS WYETH'S TORISEL NDA PRIORITY REVIEW STATUS

Wyeth Pharmaceuticals has announced that the FDA has accepted and granted priority review to the company's new drug application (NDA) for Torisel (temsirolimus). Wyeth is approval of 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, according to the company. The FDA previously granted fast-track designation and orphan drug status to 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.

The application contains interim data from a three-arm, Phase III 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 current treatment for advanced RCC.

In the United States, Torisel will be available prior to FDA approval through an expanded access program.