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US FDA rejects Amgen's Xgeva in prostate cancer; more data needed

This article was originally published in Scrip

Executive Summary

Amgen's late evening revelation that the US FDA rejected the company's supplemental biologics license application (sBLA) for its RANK ligand inhibitor Xgeva (denosumab 120mg) as a treatment for men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases came as little surprise, given regulators already had expressed concern about the lack of a survival benefit in that indication with the drug and the significant adverse events, such as osteonecrosis of the jaw (ONJ).

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