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Using Denosumab (Xgeva) To Combat Skeletal Complications in Prostate Cancer

Xgeva is a monoclonal antibody that inactivates RANKL, a protein that enhances osteoclast activity and survival. By inhibiting RANKL, Xgeva prevents skeletal-related events in men with bone metastasis from prostate cancer. Under no circumstances should a man who also has multiple myeloma use Xgeva. There have been studies that compared Xgeva to zolendronic acid (Zometa). [...]

Will the FDA Approve Xgeva – It is “Up In The Air”

Prior to the formal review, the FDA has raised questions about the ultimate approval of Amgen’s Xgeva (denosumab) for men with metastatic, advanced prostate cancer who have not yet developed metastasized to the bone. Xgeva has been shown to delay tumors spreading to bones, but it does not extend life, the holy grail of the [...]

FDA Approves New Indications for Prolia® (Denosumab) for the Treatment of Bone Loss in Men with Prostate Cancer Undergoing ADT

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved two new indications for Prolia® (denosumab) as a treatment to increase bone mass in men receiving androgen deprivation therapy (ADT) for non-metastatic prostate cancer. Men receiving ADT are at high risk for developing fractures, including vertebral fractures, which can cause paralysis. "Bone loss [...]

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