European Committee Issues Positive Opinion on Torisel

Wyeth Pharmaceuticals has received a positive opinion from the European Medicines Evaluation Agency for the approval of Torisel as a first-line therapy for patients with advanced renal cell carcinoma who have at least three of six prognostic risk factors.

The committee for medicinal products for human use (CHMP)’s opinion for Torisel will now be forwarded to the European Commission for final approval, anticipated in November 2007. Torisel has an orphan medicinal product designation in the European Union for the treatment of renal cell carcinoma. Torisel inhibits the mTOR (mammalian target of rapamycin) kinase, an important regulator of cell proliferation, cell growth and cell survival, according to Wyeth.

Robert Ruffolo, president of Wyeth, said: “The CHMP’s positive opinion underscores the importance of Torisel, which has been shown to extend median overall survival in patients with advanced kidney cancer when compared with interferon-alpha.”