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Feb 13, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Xgeva regulatory update

FDA's Oncologic Drugs Advisory Committee voted 12-1 that Xgeva denosumab from Amgen does not have a favorable benefit-risk profile to prevent bone metastases in men with castration-resistant prostate cancer (CRPC). The panel did not feel that the 4.2-month improvement in bone metastasis-free survival (BMFS) vs. placebo seen in the Phase III 147 study was clinically meaningful, especially since Xgeva did not show improvement in overall survival (OS), progression-free survival (PFS)...

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