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FDA Delays Decision on Wyeth Drug

Regulators want more time to review data on the Torisel kidney cancer drug.

The Food and Drug Administration has delayed by three months a decision on kidney cancer drug Torisel from




The company announced Friday that the FDA wanted an extra three months to review additional data that it has requested from Wyeth on the drug. The original FDA action date was April 5. (U.S. stock markets were closed Friday in observance of Good Friday.)

"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," said Robert Ruffolo, Jr., a senior vice president, in prepared comments Friday.

Torisel is in line to become the third therapy designed specifically for advanced kidney cancer. The FDA approved Nexavar from

Onyx Pharmaceuticals





in December 2005. Nexavar had worldwide sales of $165 million last year.


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Sutent was approved by the FDA in January 2006 for advanced kidney cancer and a rare form of stomach cancer. Sutent produced $219 million in sales last year, including $167 million in the U.S.

Torisel also is

one of six Wyeth products that the FDA is expected to review this year. Wyeth is waiting for the agency's verdict on drugs to treat schizophrenia, depression and the symptoms of menopause as well as for a ruling on an oral contraceptive and a drug designed to prevent osteoporosis.

In a related matter, Wyeth says the FDA has completed a reinspection of a Puerto Rico plant cited for

manufacturing problems by the agency in May 2006. Wyeth said Thursday it will respond to FDA's questions by mid-April, adding that it is "hopeful" the FDA "will be able to determine in the near future that the

manufacturing issues have been satisfactorily resolved."

Until the matter is settled, Wyeth is prohibited from making several drugs (including the oral contraceptive, and treatments for menopause symptoms and depression) that are awaiting FDA approval.

Wyeth said the plant also was inspected in late March by the European Union's counterpart to the FDA. There were "no critical or major observations, and Wyeth received a positive evaluation of the site's compliance status," the company said.