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FDA Panel Rejects Prostate Cancer Pill

September 14, 2005
A Food and Drug Administration advisory committee has recommended against approval for a new pill to treat prostate cancer. The committee turned a unanimous thumbs-down after reviewing an FDA staff report questioning the research backing the application.

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The report said studies by the pill’s maker, Abbott Labs, lack statistical significance to merit an endorsement. The FDA, which normally follows its panels’ recommendations, is set to formally consider the pill, called Xinlay, next month.

The committee’s recommendation came as no surprise to many pharmaceutical analysts, since Abbott’s application did not show that Xinlay was effective in at least two clinical trials. In the wake of the Vioxx debacle, they said, the FDA would likely err on the side of caution.

“Xinlay is an investigational, oral, once-daily, non-hormonal, non-chemotherapy agent that is currently in Phase II and III clinical trials for prostate cancer. Trials are also under way in brain, lung, kidney, and ovarian cancers,” Abbott said in a statement.

“Xinlay belongs to a class of compounds called selective endothelin-A receptor antagonists. SERAs are being investigated for their potential to block the activity of a protein, endothelin, thought to be involved in the stimulation of the spread of cancer cells.

FDA staff suggested the pharmaceutical maker needs to do more to show Xinlay’s effectiveness and prove a more clear benefit. Abbott reportedly has additional research in the works that may address the panel's concerns.

Member of the advisory committee said the Abbott drug showed "activity" in patients and encouraged the company to bring the Xinlay back for review additional studies are available.

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