FDA Approves Torisel for Renal Cell Carcinoma

June 1, 2007

FDA has approved Wyeth's Torisel (temsirolimus) for the treatment of advanced renal cell carcinoma, based on a study showing prolonged survival with Torisel as a single agent vs interferon alfa

ROCKVILLE, Maryland—FDA has approved Wyeth's Torisel (temsirolimus) for the treatment of advanced renal cell carcinoma, based on a study showing prolonged survival with Torisel as a single agent vs interferon alfa. Median overall survival was 10.9 months for Torisel patients vs 7.3 months for interferon patients. Progression-free survival increased from 3.1 months with interferon to 5.5 months with Torisel. The combination of Torisel and interferon did not result in a significant increase in overall survival, compared with interferon alone. Look for a complete report on the approval in the July issue of ONI.