Xgeva Comes Up Short On Clinical Benefit, Has Too Much Risk, ODAC Tells FDA
This article was originally published in The Pink Sheet Daily
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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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.
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.
It is becoming ever more clear that the overriding factor in NICE’s decision-making process is a desire to see cost-effectiveness, irrespective of the clinical benefit of a drug. But in Germany, companies are challenged by IQWiG’s tightened-up, science-based review system.