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FDA To Decide By April 26 On New Xgeva Application

Prevention of metastases represents promising new use for Xgeva

Amgen today announced the FDA plans to decide by April 26 on its application to expand the use of its bone treatment drug Xgeva to prevent or delay the spread of advanced prostate cancer. The drug is currently used to prevent bone related events such as bone loss and fractures in men undergoing androgen deprivation therapy.

In trials for the new indication, Amgen has reported that Xgeva outperformed a placebo in a late-stage study of how it works in preventing the spread of advanced prostate cancer to bones where prostate cancer is most likely to spread. A monthly treatment of the injectable drug increased bone metastasis-free survival by about four months on average compared with a placebo.

“This is very promising news for patients, says Jonathan W. Simons, president and CEO of the Prostate Cancer foundation which has funded many studies related to Xgeva for improving survivorship of patients. “Not only can Xgeva prevent damage to bone as a result of treatment, it looks as if we may soon have a powerful new tool to prevent bone metastases.”

This story originally published by the Prostate Cancer Foundation.

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