Xgeva (denosumab), which has already been approved by the Food and Drug Administration (FDA) for the prevention fractures in men with advanced prostate cancer that has already migrated to the bone, has been rejected by the FDA to expand the use of the drug to delay the spread of tumors in men without metastases to the bone in patients suffering from advanced prostate cancer.

The FDA has determined that the risks of taking the drug outweigh the positve effects. The FDA has asked for additional data from adequate and well-controlled trials.

The FDA decided to reject the application for the expanded use of denosumab after an advisory panel voted against it. The advisory panel expressed concern because of the rugs link to a jawbone-destroying condition (ONJ).

According to Sean Harper, executive vice president of research and development at Amgen, they intend to gather the requested information. He said, “We will work with FDA to determine any next steps.”

The FDA’s action does not impact the already approved indication of Xgeva in the prevention of fractures in men suffering from advanced prostate cancer who already have bone metastases.

Joel T. Nowak, M.A., M.S.W.