The U.S. Food and Drug Administration (FDA) hasapproved Torisel (temsirolimus) for the treatment of a certain type of advanced kidney cancer known as renal cell carcinoma.
Torisel was approved based on a study that showed use of 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), which was based on a delay in progression of disease. In January 2006, Sutent (sunitinib) received accelerated approval based on durable response rate, or tumor size reduction, and was later demonstrated to delay tumor progression.
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.