A latest report has unveiled that the Food and Drug Administration has voted against the wider use of Amgen Inc's drug Xgeva that is used for prevention of prostate cancer. It is being claimed by the FDA board that the benefits of Xgeva are not able to offset the risk of prostate cancer which could affect bones.
It has been revealed by the report that U. S. health regulators have been urged by an advisory panel on Wednesday to deny the approval of the drug. The drug is found to cause no additional benefits that could prevent a jaw bone disease from occurring in patients with prostate cancer.
The report says that the FDA, however, follows the panel?s recommendation always, it has refused to agree with its decision of approval for the drug this time. It is based on the evidence that the drug was found to help patients of prostate cancer in preventing the spread of cancer to the bone for only slightly more than four months.
As per the report, more than 1400 men with prostate cancer, who were not responding to hormone therapy, were examined in the study. And it was found by the team of analysts that one in every 15 people who were given the drug tended to grow osteonecrosis of the jaw. The disease in which jawbone tissue dies and the bone is exposed, is caused as a side effect of the drug.
Therefore, the FDA has criticized the approval of the drug questioning whether its benefit of preventing the spread of cancer to bone was really meaningful. Also, it has suggested stopping the use of the drug as it does not help men to survive for long or in averting the further development of prostate cancer.
Source: http://topnews.us/content/246163-fda-criticizes-xgeva-drug-prostate-cancer
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