The Food and Drug Administration’s advisory committee has recommended against approving a drug made by Abbott Laboratories to treat prostate cancer. The reason cited was safety concerns. The vote was unanimous.
The drug, atrasentan, has the trade name Xinlay. It was supposed to be used for patients with advanced prostate cancer that had spread to the bone.
Abbott indicated it would continue research on Xinlay for patients suffering from less advanced forms of prostate cancer. The study is expected to be completed sometime in 2006.
In addition to safety concerns, the committee found that the drug may not be all that effective in helping patients with severe prostate cancer.
While the committee's recommendation is not binding on the FDA, it is almost always followed.
A spokesman for Abbott indicated the company still believes the medication can be effective and that it will continue researching the benefits of Xinlay.
