Advisory panel does NOT recommend approval of Xgeva for prevention of bone mets

According to an online report in The Washington Post earlier this afternoon, an advisory panel to the U.S. Food and Drug Administration (FDA) has voted 12 to 1 not to recommend the approval of denosumab (Xgeva®) for the prevention of bone metastasis in men with non-metastatic, castrate-resistant prostate cancer.

The advisory committee appears to have concurred with the FDA’s internal reviewers that the benefits of such treatment did not significantly outweigh the potential risks, as discussed in a commentary on this web site earlier in the week.

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