FDA approves third new targeted therapy for advanced RCC

June 7, 2007

The FDA has approved the enzyme inhibitor temsirolimus (Torisel) for the treatment of advanced renal cell carcinoma.

The FDA has approved the enzyme inhibitor temsirolimus (Torisel) for the treatment of advanced renal cell carcinoma.

The approval of temsirolimus follows the December 2005 approval of sorafenib (Nexavar) and the January 2006 approval of sunitinib (Sutent), which represent a new class of targeted therapies for advanced RCC.

"We have made significant advances in the battle against kidney cancer," said Steven Galson, MD, MPH, 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 safety and effectiveness of temsirolimus were shown in a clinical trial of 626 patients published last week in the New England Journal of Medicine (2007; 356:2271-81). The patients were divided into three groups: One group received temsirolimus alone, another received interferon alfa (Intron A, Roferon-A), and a third received a combination of temsirolimus and interferon.

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

"This is a modest improvement in survival, but the patients in the study had the most advanced tumors," said lead author Gary R. Hudes, MD, of Fox Chase Cancer Center, Philadelphia. "It would be reasonable to hypothesize that temsirolimus could provide greater benefit to patients with less extensive metastatic disease. Only a randomized, clinical trial will give us that definitive knowledge."

The New England Journal of Medicine study was supported by Wyeth Research.