The US Food and Drug Administration has approved the drug temsirolimus for advanced renal cell carcinoma, a form of kidney cancer. The announcement coincides with the publication this week of a study showing the drug helps people with this late-stage disease live longer.

Temsirolimus, made by Wyeth, will be sold under the name Torisel. It is one of 3 drugs recently approved for kidney cancer but the only one so far that has been shown to improve survival. Studies thus far have shown that Nexavar (sorafenib, made by Bayer Healthcare and Onyx Pharmaceuticals) delays the time it takes for the cancer to start growing again, while Sutent (sunitinib, made by Pfizer Oncology) also delays tumor growth and shrinks tumors.

In the new study, published in this week's issue of the New England Journal of Medicine, people who took Torisel lived an average of about 11 months, compared to about 7 months for those treated with interferon, a standard therapy for late-stage kidney cancer. In addition, those on Torisel went more than 5 months before their disease began to get worse, compared to about 3 months for people on interferon.

Torisel is given by infusion into a vein. The most common side effects include rash, fatigue, mouth sores, nausea, swelling, and loss of appetite. The drug can also raise blood sugar, cholesterol, and triglyceride levels, and lower blood counts.

Torisel is a targeted drug that blocks growth signals and blood vessel formation in tumors. It is being studied as a treatment for several other types of cancer, including mantle cell lymphoma, solid tumors, brain tumors, melanoma, and ovarian cancer.

Torisel should be available to patients in July, according to Wyeth.