In an unexpected development, Wyeth says the FDA wants another three months to review recently submitted data for its Torisel kidney-cancer drug. The application was filed Oct. 5, and given priority review, which meant agency approval was widely expected today.

As it turns out, Wyeth recently submitted additional info at the FDA’s request. A Wyeth spokeswoman tells Pharmalot the issue is not related to safety, but that the FDA wants to know whether Torisel was able to stop tumors from spreading to other parts of the body.

“We are encouraged by the review process so far, and, with the submission of these analyses, we remain optimistic about the prospects for strengthening the product labeling for launch in the third quarter of 2007,” says Bob Ruffolo, a Wyeth senior vp who heads research.

If approved, Torisel would be only the third new drug in two decades to fight advanced renal cell carcinoma. Along with Pfizer’s Sutent and Bayer’s Nexavar, these med block the growth of cancer cells, different from chemotherapy that kills tumors and can harm nearby tissues.

The Wyeth drug prolonged survival by 50 percent in a study of the sickest type of kidney-cancer patients, while Sutent and Nexavar, both introduced last year, slowed tumor growth in tests. About 51,000 Americans will be diagnosed with kidney cancer this year, and Wyeth has previously indicated its drug could one day generate $500 million in annual sales.

Wyeth statement;
Bloomberg News story today;
Bloomberg News story earlier this week that approval was imminent.
[tags]Torisel, Wyeth[/tags]