Wyeth Pharmaceuticals’ Torisel has been approved for the treatment of renal cell carcinoma (RCC). The drug, administered via injection, specifically inhibits the mTOR (mammalian target of rapamycin) kinase, a protein that regulates cell proliferation, cell growth, and cell survival. It is the first mTOR inhibitor okayed for this indication as well as the only targeted therapy proven to extend overall survival, according to the company.
“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," remarks Steven Galson, M.D., director of the FDA’s Center for Drug Evaluation and Research.
In December 2005, Nexavar, developed by Bayer Healthcare Pharmaceuticals and Onyx Pharmaceuticals, was sanctioned as it delayed progression of the disease. In January 2006, Pfizer’s Sutent received accelerated approval based on tumor size reduction and later demonstrated a delay in 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 interferon alfa, and a third received a combination of Torisel and interferon.
As part of a postmarketing commitment, Wyeth agreed to submit two study reports and data sets: one on a thorough QT prolongation study and one on an ongoing hepatic impairment study.