Wyeth Pharmaceuticals (Wyeth) has filed new drug application to the U.S. Food and Drug Administration and marketing authorization application to the European Medicines Agency for Torisel™ (temsirolimus), an mTOR kinase inhibitor for the treatment of advanced renal cancer.
If approved, Torisel would be the first agent in this class indicated for the treatment of a cancer. The application follows the positive results from a recently concluded Phase III clinical trial.
The results showed that treatment with Torisel increased median overall survival time by 3.6 months, or by 49 percent, compared with treatment with interferon-alpha ( 10.9 months vs. 7.3 months, p=0.0069).
Other details of the study and background information on Torisel are described in Wyeth's press release.
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