Wyeth Pharmaceuticals has submitted a New Drug Application (NDA) for Torisel (temsirolimus) for treating advanced renal cell carcinoma. The company has initiated a similar filing in Europe. The NDA contains interim data from a Phase III clinical trial of 626 patients showing that the drug increased median overall survival time by 3.6 months (49%) compared with treatment with interferon-alpha (10.9 vs. 7.3 months). The drug specifically inhibits the mTOR (mammalian target of rapamycin) kinase, a protein that regulates cell proliferation, cell growth, and cell survival.
