Torisel (temsirolimus), an enzyme inhibitor, has received approval for advanced renal cell carcinoma (RCC) following a study of 626 patients.
In the study, a group of patients receiving Torisel alone showed a significant improvement in median overall survival compared with a group given interferon alfa: 10.9 vs. 7.3 months, respectively. A combination of the drugs used to treat a third group did not show a significant survival increase compared with interferon alone.
“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,” said Steven Galson, MD, MPH, director of the FDA’s Center for Drug Evaluation and Research. Enzyme inhibitors such as temsirolimus are proteins that regulate the proliferation, growth, and survival of cells.
Wyeth Pharmaceuticals, Inc., the manufacturer, expects Torisel to be available to patients this month.