Prolia (denosumab)

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). They concluded that the men using Xgeva had a longer period of time before they developed a skeletal-related event (bone metastases or fracture) then those men who received zolendronic acid. Despite this, overall survival was not improved. When receiving Xgeva you should have normal calcium [...]

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. The FDA will be holding on February 8 an advisory panel that will meet to recommend whether to expand Xgeva’s use (currently it is approved for men who have developed bone metastasizes) to include men with advanced prostate cancer who have not yet developed [...]

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 and fractures are recognized adverse effects of hormone ablation therapies but we have not had an approved treatment option to prevent these problems for our patients," said Matthew Smith, M.D., Ph.D., director of the Genitourinary Malignancies Program at Massachusetts General Hospital Cancer Center, Boston. "Prolia [...]

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