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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P07-95
May 30, 2007

Media Inquiries:
Susan Cruzan and Sandy Walsh,
301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Approves New Drug for Advanced Kidney Cancer

The U.S. Food and Drug Administration (FDA) today approved Torisel (temsirolimus) for the treatment of a certain type of advanced kidney cancer known as renal cell carcinoma. Torisel was approved based on a study that showed use of the drug prolonged survival of patients with renal cell carcinoma. The drug is an enzyme inhibitor, a protein that regulates cell production, cell growth and cell survival.

"We have made significant advances in the battle against kidney cancer,” said Steven Galson, M.D., M.P.H., director of the FDA’s Center for Drug Evaluation and Research. "Torisel is the third drug approved for this indication in the past 18 months, and one that shows an increased time in survival for some patients."

The approval of Torisel follows the December 2005 approval of Nexavar (sorafenib), which was based on a delay in progression of disease. In January 2006, Sutent (sunitinib) received accelerated approval based on durable response rate, or tumor size reduction, and was later demonstrated to delay tumor progression.

The safety and effectiveness of Torisel were shown in a clinical trial of 626 patients divided into three groups. One group received Torisel alone, another received a comparison drug called Interferon alfa, and a third received a combination of Torisel and interferon.

The group of patients who received Torisel alone showed a significant improvement in overall survival. The median overall survival was 10.9 months for patients on Torisel alone versus 7.3 months for those treated with the interferon alone. Progression-free survival (when the disease does not get worse) increased from 3.1 months on the interferon alone arm to 5.5 months on the Torisel alone arm. The combination of Torisel and interferon did not result in a significant increase in overall survival when compared with interferon alone.

The most common adverse reactions, occurring in at least 30 percent of Torisel-treated patients, were rash, fatigue, mouth sores, nausea, edema, and loss of appetite. The most common laboratory abnormalities were high blood sugar, elevated blood lipids and triglycerides, elevated liver and kidney blood tests, and low red cell, white cell, and platelet counts.

Renal cell carcinoma, diagnosed in about 51,000 people annually in the United States, accounts for about 85 percent of all U.S. adult kidney cancer.

Torisel is manufactured by Philadelphia-based Wyeth Pharmaceuticals, Inc.

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