FDA OKs New Kidney Cancer Drug

May 31, 2007 -- The FDA has approved a new drug called Torisel (temsirolimus) to treat renal cell carcinoma, which is a type of aggressive kidney cancer.

Torisel has been shown to increase patients' survival time, notes Steven Galson, MD, MPH, who directs the FDA's Center for Drug Evaluation and Research.

"We have made significant advances in the battle against kidney cancer. Torisel is the third drug approved for this indication in the past 18 months," says Galson in an FDA news release.

Torisel's maker, Wyeth Pharmaceuticals, says it expects the drug to be available by July.

Torisel inhibits a protein called mTOR that regulates cell production, cell growth, and cell survival.

The FDA approved Torisel based on a clinical trial of 626 patients split into three groups. One group of patients only took Torisel. Another group only took a comparison drug called interferon alpha. Patients in the third group took a combination of Torisel and interferon.

Most patients who only took Torisel lived at least 11 months, compared with 7.3 months for those who only took interferon. That's a difference of about 3.5 months.

In addition, renal cell carcinoma generally took about two months longer to worsen in patients who only received Torisel, compared with those who were only given interferon.

The Torisel-interferon combination didn't significantly improve survival.

The most common adverse reactions, occurring in at least 30% of Torisel-treated patients in the clinical trial, were rash, fatigue, mouth sores, nausea, edema, and loss of appetite.

Renal cell carcinoma, diagnosed in about 51,000 people annually in the U.S., accounts for about 85% of all U.S. adult kidney cancer, according to the FDA.