WASHINGTON – A Food and Drug Administration advisory committee on Tuesday recommended against approval of a drug intended to treat prostate cancer (search) following a report that questioned its safety and effectiveness.
Abbott Laboratories (search) presented atrasentan (search), which has the trade name Xinlay (search), as a treatment for men with an advanced stage of prostate cancer that has spread to the bone. But the FDA's Oncologic Drugs Advisory Committee voted unanimously against recommending it.
The FDA typically follows the advice of its committees but isn't required to.
Abbott said it would continue to study Xinlay, a once-a-day pill, for use in patients with a less developed form of prostate cancer. That study would be finished in 2006.
The drug works by hindering a protein believed to play a role in the growth of cancer cells, the company said.
FDA staff documents released this week noted several weaknesses in the company's studies of the drug and argued the company had not shown the drug was effective in slowing the progression of cancer.