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Wyeth's Torisel Receives European Commission Approval for the Treatment of Advanced Kidney Cancer Torisel Extends Median Overall Survival vs. Interferon-Alpha COLLEGEVILLE, PA -- November 26, 2007 -- Wyeth Pharmaceuticals, a division of Wyeth, announced today that the European Commission has approved Torisel (temsirolimus) for the first-line treatment of patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors. Torisel is the only approved cancer therapy that specifically inhibits the mTOR (mammalian target of rapamycin) kinase, an important regulator of cell proliferation, cell growth and cell survival. Torisel was approved in the United States in May 2007 for the treatment of advanced RCC. Renal cell carcinoma accounts for approximately 85 percent of the estimated 85,000 new cases of kidney cancer diagnosed in Europe annually. Torisel is the only renal cancer therapy proved to extend median overall survival compared with interferon-alpha in patients with advanced RCC. "Temsirolimus was studied in the most difficult-to-treat patients with advanced renal cell carcinoma: those who have multiple risk factors that have been associated with shortened survival," says Bernard Escudier, M.D., Head of the Immunotherapy Unit, Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France, and an investigator in the Torisel phase 3 study. "The ability of temsirolimus to provide an increase in overall survival in these patients provides us with a much-needed new option for the treatment of advanced kidney cancer." Torisel was studied in a three-arm, Phase 3 clinical trial of 626 patients with advanced RCC and three or more of six preselected prognostic risk factors who had received no prior systemic therapy. In the study, Torisel significantly increased median overall survival by 49 percent compared with interferon-alpha (10.9 months vs. 7.3 months, P=0.0078). Torisel also was associated with a statistically significant improvement over interferon-alpha in the secondary endpoint of progression-free survival (when the disease does not worsen; 5.6 months vs. 3.2 months, P=0.0042). The combination of Torisel and interferon-alpha did not result in a significant increase in overall survival when compared with interferon-alpha alone. SOURCE: Wyeth E-mail this page to a friend or colleague! To print, use this version