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Xgeva Comes Up Short On Clinical Benefit, Has Too Much Risk, ODAC Tells FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

The oncologic drugs panel rejects an expanded indication for Amgen’s denosumab, saying a 4.2-month delay in progression of bone metastasis in castrate-resistant prostate cancer patients does not offset the risk of osteonecrosis of the jaw.

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