European approval of renal cell carcinoma treatment

The European Commission has approved Torisel (temsirolimus) for the first-line treatment of patients with advanced renal cell carcinoma (RCC), a condition that accounts for more than 80% of the estimated 85000 new cases of kidney cancer diagnosed in Europe every year. Torisel, developed by Wyeth Pharmaceuticals, is currently the only approved cancer therapy that specifically inhibits the mammalian target of rapamycin kinase, an important regulator of cell proliferation, cell growth and cell survival. The treatment is also proven to extend median overall survival in patients with advanced RCC, compared with the medication interferon-alpha (10.9 months compared with 7.3 months).

"Temsirolimus was studied in the most difficult to treat patients with advanced RCC: those who have multiple risk factors and have been associated with shortened survival," says Bernard Escudier, an investigator in the Phase III study. "The ability of temsirolimus to provide an increase in overall survival in these patients provides us with a much needed new option for treatment."

The drug will be used in patients with advanced RCC who have at least three of six prognostic risk factors including less than 1 year from time of initial diagnosis to randomization and a Karnofsky performance status of 60 or 70.

In the US, Torisel was approved in May 2007 for the treatment of advanced RCC and in August, it was added to the National Comprehensive Cancer Network Kidney Cancer Guidelines as an option in first line therapy for predominant clear cell histology and nonclear cell histology.

Robert R. Ruffolo, Jr., senior vice president of Wyeth, says: "The European Commission's approval of Torisel underscores the importance of this therapy for patients with advanced RCC and reinforces the potential of this mechanism of action as a new approach in oncology."

www.wyeth.com