Wyeth Cancer Drug Cleared

The Food and Drug Administration has approved Wyeth's (WYE Quote) Torisel for treating a type of advanced kidney cancer.

Torisel is the third drug approved by the FDA for renal cell carcinoma in the last 18 months. The agency endorsed Nexavar from Onyx Pharmaceuticals(ONXX Quote) and Bayer(BAY Quote) in December 2005, and it approved Pfizer's(PFE Quote) Sutent in January 2006.

The Wyeth drug was cleared based on clinical trials showing it prolonged patients' survival. The median overall survival was 10.9 months for patients on Torisel vs. 7.3 months for those treated with interferon. The comparison was statistically significant.

However, patients receiving a combination of Torisel and interferon didn't show a significant improvement in survival against patients receiving interferon.

The FDA had been scheduled to rule on Torisel in early April, but it said it needed 90 more days to review additional data. Wednesday's announcement came well ahead of the revised FDA deadline.

Torisel is the second Wyeth drug to receive the FDA green light this month. Last week, the agency endorsed the oral contraceptive Lybrel, which eliminates menstrual periods. The FDA is expected to act this year on several other products, including treatments for schizophrenia and menopausal symptoms and a drug to prevent osteoporosis.