The FDA granted priority review status to Wyeth Pharmaceuticals’ NDA related to its therapy against advanced renal cell carcinoma (RCC). Torisel™ (temsirolimus) is the first mTOR (mammalian target of rapamycin) inhibitor to be filed for approval for the treatment of a cancer, the company reports. It is an investigational drug that specifically inhibits the mTOR kinase, a protein that regulates cell proliferation, cell growth, and cell survival.
The FDA previously granted fast-track designation and orphan drug status for investigational temsirolimus for the same indication.
The application contains interim data from a three-arm, Phase III trial of 626 patients who had received no prior systemic therapy. Wyeth says the results showed that Torisel significantly increased overall survival by 49% in patients with advanced RCC compared with interferon-alpha, a treatment for advanced RCC.