Leading the Way in Life Science Technologies

GEN Exclusives

More »

GEN News Highlights

More »
Dec 19, 2006

Wyeth’s Renal Cell Carcinoma Drug Gets NDA Priority Review Status

  • 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.



Be sure to take the GEN Poll

Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

Do you agree that ecstasy should be studied for its potential therapeutic benefits?

More »