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

This article was originally published in The Pink Sheet Daily

Executive Summary

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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Amgen Needs To Show Xgeva Does More Than Delay Bone Metastases, ODAC Says

Measurement of a downstream endpoint, such as delay in skeletal-related events, could have been better than radiographic scans to assess efficacy of denosumab in delaying bone metastases in high-risk castration-resistant prostate cancer patients, several ODAC members contend.

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.

Amgen’s Xgeva For Castration-Resistant Prostate Cancer Faces Panel Review Without Overall Survival Advantage

Delaying or preventing bone metastasis is an important clinical benefit for patients, an FDA official said recently. The Oncologic Drugs Advisory Committee will share its opinion about the product on Feb. 8.

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