05.30.07—The Food and Drug Administration (FDA) has approved a new kidney cancer drug with Wyeth’s Torisel™ (temsirolimus), specifically 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.

In a three-arm, phase III clinical trial of 626 patients with advanced RCC and poor prognosis who had received no prior systemic therapy, Torisel significantly increased median overall survival by 49 percent compared with interferon-alpha (10.9 months versus 7.3 months). Torisel was also associated with a statistically significant improvement over interferon-alpha in progression-free survival (when the disease does not get worse; 5.5 months versus 3.1 months). The combination of Torisel and interferon-alpha did not result in a significant increase in overall survival when compared with interferon-alpha alone.

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. In in vitro studies using cancer cells, mTOR inhibition blocked the translation of genes that regulate the cell cycle. mTOR inhibition also resulted in reduced levels of certain cell growth factors involved in the development of new blood vessels, such as vascular endothelial growth factor.

Wyeth anticipates that Torisel will be available to patients in July 2007. The company 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.

Torisel joins the ranks of two other recently approved RCC drugs, Nexavar® (sorafenib) and Sutent® (sunitinib), which were approved in December 2005 and July 2005, respectively.

Renal cell carcinoma accounts for approximately 85 percent of kidney cancers. The American Cancer Society estimates that 51,190 new cases of kidney cancer will be diagnosed this year, and more than 40 percent of these patients are initially diagnosed with advanced disease.

For more information on Torisel, go to www.wyeth.com.