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.
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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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