U.S. approves Wyeth kidney cancer drug

U.S. health regulators on Wednesday approved Wyeth's drug Torisel for patients with an advanced form of kidney cancer called renal cell carcinoma, saying it helped them live longer.

The drug, known chemically as temsirolimus, is the third such therapy approved since late 2005 for the disease -- the most common form of kidney cancer, the U.S.Food and Drug Administration said.

In December 2005, the FDA cleared Bayer and Onyx Pharmaceuticals Inc.'s Nexavar, or sorafenib. In January 2006, Pfizer Inc.'s Sutent, or sunitinib, also won approval.

"The group of patients who received Torisel alone showed a significant improvement in overall survival," the FDA said.
Wyeth, in a statement, said its drug would be available for patients in July.

Shares of the drugmaker earlier closed down 27 cents, or less than 1 percent, at $57.50 on the New York Stock Exchange.

Company data on Torisel showed that patients who took it alone lived 3.5 months longer overall than those who took it with the cancer drug interferon or a combination of the two, the FDA said.

Interferon is sold under several brand names. Wyeth's study used Roche's Roferon-A.

Torisel patients survived for about 10.9 months compared with 7.3 months for those taking just interferon and 8.4 months in those taking both. Combining the two drugs "did not result in a significant increase in overall survival when compared with interferon alone," the FDA added.

Common side effects with Torisel included rash, fatigue, mouth sores and nausea, among others, the FDA said. High blood sugar, elevated blood lipids and low blood cell counts were also found.

Results from the company-sponsored study of 626 patients were reported on Wednesday in the New England Journal of Medicine.

Wyeth is also studying Torisel to treat lymphoma.

About 51,000 U.S. cases of renal cell carcinoma are diagnosed each year, according to the FDA.