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FDA Approves Amgen's Denosumab For First Oncology Indication

This article was originally published in The Pink Sheet Daily

Executive Summary

Known as Prolia for osteoporosis, the drug will be called Xgeva for skeletal-related events related to metastasized solid-tumor cancers.

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Amgen’s Xgeva Gains FDA Nod For Use In Rare Bone Tumor

Approval of denosumab for giant cell tumor of the bone comes more than a year after Amgen’s failed bid to add a more commercially significant indication for prevention of bone metastases in patients with castrate-resistant prostate cancer.

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

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.

Xgeva Prostate Cancer Claim May Not Benefit Beyond Existing Cancer Indication, FDA Says

The agency will ask the Oncologic Drugs Advisory Committee whether delaying bone metastases in high-risk castrate-resistant prostate cancer patients provides benefit above that obtained with current use of t drug to delay skeletal-related events and is worth a potentially higher risk for osteonecrosis of the jaw.

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