FDA priority review for Wyeth's Torisel

The US Food and Drug Administration has accepted the file and granted priority review status to drug major Wyeth Pharmaceuticals' New Drug Application for the investigational drug Torisel (temsirolimus). The company is seeking an indication for Torisel for the treatment of advanced renal cell carcinoma (RCC).

Torisel is the first mTOR (mammalian target of rapamycin) inhibitor to be filed for approval for the treatment of a cancer. It is an investigational drug that specifically inhibits the mTOR kinase, a protein that regulates cell proliferation, cell growth and cell survival.

"Renal cell carcinoma continues to be an extremely difficult-to-treat form of cancer, and there continues to be a need for new therapies. Torisel has demonstrated its potential to help meet that important medical need," says Lee Allen, vice president of oncology clinical research at Wyeth.