FDA Approved New Kidney Cancer Drug: Toriselâ„¢ (temsirolimus) by Wyeth

Filed in archive News , Treatment on June 1, 2007

Wyeth's Toriselâ„¢ (temsirolimus) has recently been approved by the FDA for the treatment of renal cell carcinoma.

Renal cell carcinoma is a type of advanced kidney cancer.

According to Gary Hudes, M.D., Director, Genitourinary Malignancies Program, Fox Chase Cancer Center, Philadelphia, and lead investigator of the phase 3 trial of TORISEL in advanced RCC:

"Advanced renal cell carcinoma can be a devastating diagnosis for patients and their families because the disease is very difficult to treat. Developing effective treatments for this stage of disease is a major challenge.

Temsirolimus is the first drug to demonstrate a significant increase in overall survival for patients with the most aggressive form of kidney cancer, providing us with a new and much needed option for treatment."

The said Phase II clinical trial, where Toriselâ„¢ have demonstrated prolonged survival in renal cell carcinoma patients - as recently reported at the New England Journal of Medicine - had been the basis of this FDA approval.

[TORISELâ„¢ is the first targeted renal cancer therapy proven to extend median overall survival versus interferon-alpha, an active comparator, in this patient population.]

TORISELâ„¢ - the only marketed cancer therapy that specifically inhibits the mTOR (mammalian target of rapamycin) kinase [a key protein in cells that regulates cell proliferation, cell growth and cell survival] is expected to be available to patients by July.

Find more details from the full report.