Originally published September 26 2005
Prostate cancer drug voted down by FDA committee
by Mike Adams, the Health Ranger, NaturalNews Editor
When Abbott Laboratories presented atrasentan (named Xinlay) to the FDA, the committee voted unanimously against approval, citing holes in the company's research on the drug's effectiveness against advanced prostate cancer.
Food and Drug Administration advisory committee on Tuesday recommended against approval of a drug intended to treat prostate cancer following a report that questioned its safety and effectiveness.
Abbott Laboratories presented atrasentan, which has the trade name Xinlay, 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.
Eugene Sun, vice president of global pharmaceutical clinical development for North Chicago, Ill.-based Abbott, said the company respects the committee's decision but continues to believe Xinlay could help patients with advanced prostate cancer.
"The company is encouraged by committee member statements regarding the activity of Xinlay and the value of continuing development of the drug," he 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.
All content posted on this site is commentary or opinion and is protected under Free Speech. Truth Publishing LLC takes sole responsibility for all content. Truth Publishing sells no hard products and earns no money from the recommendation of products. NaturalNews.com is presented for educational and commentary purposes only and should not be construed as professional advice from any licensed practitioner. Truth Publishing assumes no responsibility for the use or misuse of this material. For the full terms of usage of this material, visit www.NaturalNews.com/terms.shtml