Wyeth has received FDA approval to market Torisel for patients with advanced renal cell carcinoma (RCC). Torisel is the first targeted renal cancer therapy proven to extend median overall survival versus interferon- alpha, an active comparator, in this patient population, according to Wyeth.

Torisel is the only marketed cancer therapy that specifically inhibits the mTOR (mammalian target of rapamycin) kinase, a key protein in cells that regulates cell proliferation, cell growth and cell survival. Wyeth anticipates that Torisel will be available to patients in July 2007.

In a three-arm, Phase III trial of 626 patients with advanced RCC and poor prognosis who had received no prior systemic therapy, Torisel increased median overall survival by 49% compared to interferon-alpha. It was also associated with a statistically significant improvement over interferon-alpha in the secondary endpoint of progression-free survival. As part of a postmarketing commitment, Wyeth has agreed to submit two completed study reports and data sets: one on a thorough QT prolongation study and one on an ongoing hepatic impairment study.

“The approval of Torisel for the treatment of advanced RCC reinforces the potential of mTOR inhibition as a new approach in oncology. This milestone demonstrates Wyeth’s commitment to developing innovative therapies for cancer. In addition to Torisel, we have five oncology treatments currently in human trials for various cancers, and we are dedicated to research into new therapies that have the potential to address unmet medical needs,” says Robert R. Ruffolo, Ph.D., president, Wyeth Research.