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Xgeva Rejection Shows What’s Needed For Non-Metastatic CRPC Approvals

This article was originally published in The Pink Sheet Daily

Executive Summary

As expected, FDA rejected the new indication for Amgen’s bone drug Xgeva in prevention of bone metastases. But the door is still open for other therapies for castration resistant prostate cancer to target earlier stages of disease.

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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.

Momentum In Prostate Cancer Therapy Moves Up To First-Line CRPC

The most recent events in the fast-evolving castration-resistant prostate cancer field illustrate how the major advances in therapy for patients who failed chemotherapy are now spreading to the larger population of CRPC patients receiving first-line therapy for metastatic disease. The upcoming year should see Phase III results from candidates ranging from a kinase inhibitor to an antisense agent.

NICE Backs Xgeva for Oncology But Excludes Prostate Cancer Indication

A significant discount from Amgen has left NICE more than happy to pass Xgeva, but it still found economic grounds to reject the company’s application for a prostate cancer indication.

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