EC approves Wyeth's Torisel in advanced RCC

US drug major Wyeth says that 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 six prognostic risk factors. The agent is the only approved cancer therapy that specifically inhibits the mammalian target of rapamycin kinase, an important regulator of cell proliferation, growth and survival. Torisel was approved in the USA ealier this year for the treatment of advanced RCC (Marketletter June 18).

Renal cell carcinoma accounts for approximately 85% of the estimated 85,000 new cases of kidney cancer diagnosed in Europe each year. Wyeth noted that its drug is the only renal cancer therapy proved to extend median overall survival compared with interferon-alpha in patients with advanced RCC.

Torisel was studied in a three-arm, Phase III clinical trial of 626 patients with advanced RCC and three or more of six pre-selected prognostic risk factors who had received no prior systemic therapy. In the study, Torisel significantly increased median overall survival 49% compared with INF-alpha (10.9 months versus 7.3 months, p=0.0078). The agent was also associated with a statistically-significant improvement over INF-alpha in the secondary endpoint of progression-free survival (5.6 months vs 3.2 months, p=0.0042). The combination of Torisel and INF-alpha did not result in a significant increase in overall survival when compared with INF-alpha alone.