FDA Approves Kidney Cancer Drug

The U.S. Food and Drug Administration today approved Torisel for the treatment of the advanced kidney cancer known as renal cell carcinoma.

Torisel, which contains the active ingredient temsirolimus, was approved based on a study that showed the drug prolonged survival of patients with renal cell carcinoma. The drug is an enzyme inhibitor, a protein that regulates cell production, cell growth and cell survival.

"We have made significant advances in the battle against kidney cancer,” said Steven Galson, M.D., M.P.H., director of the FDA’s Center for Drug Evaluation and Research. "Torisel is the third drug approved for this indication in the past 18 months, and one that shows an increased time in survival for some patients."

The approval of Torisel follows the December 2005 approval of Nexavar (sorafenib), and the January 2006 accelerated approval of Sutent (sunitinib).

The safety and effectiveness of Torisel were shown in a clinical trial of 626 patients divided into three groups. One group received Torisel alone, another received a comparison drug called Interferon alfa, and a third received a combination of Torisel and interferon.

The median overall survival was 10.9 months for patients on Torisel alone versus 7.3 months for those treated with the interferon alone.

The combination of Torisel and interferon did not result in a significant increase in overall survival when compared with interferon alone.

Renal cell carcinoma, diagnosed in about 51,000 people annually in the United States, accounts for about 85 percent of all U.S. adult kidney cancer.

Torisel is manufactured by Philadelphia-based Wyeth Pharmaceuticals Inc.