Wyeth has received the green light from regulators in Europe for its first-in-class anticancer drug Torisel to be used in patients with advanced kidney cancer.

The European Commission has approved Torisel (temsirolimus) for the first-line treatment of patients with advanced renal cell carcinoma who have at least three of the aforementioned six prognostic risk factors. The targeted mTOR (mammalian target of rapamycin) inhibitor is the first targeted renal cancer therapy proven to extend median overall survival versus standard therapy with interferon-alpha.

The approval, which comes after US regulators gave the go-ahead to the drug in May, is based on a Phase III study of 632 patients who three or more of the aforementioned risk factors who had received no prior therapy. Torisel increased median overall survival by 49% compared with interferon-alpha (10.9 months versus 7.3 months), while progression-free survival also improved significantly (5.6 months versus 3.2 months). A combination of Wyeth’s drug and interferon-alpha did not result in a significant increase in overall survival.

Bernard Escudier of the Institut Gustave Roussy in Villejuif, France, and an investigator in the Phase III study, noted that Torisel 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". He added that “the ability of temsirolimus to provide an increase in overall survival in these patients provides us with a much-needed new option".

Renal cell carcinoma accounts for 85% of the estimated 85,000 new cases of kidney cancer diagnosed in Europe annually and Torisel will now compete on the Old Continent with Bayer/Onyx’ Nexavar (sorafenib) and Pfizer's Sutent (sunitinib).