A study from Michael T. Schweizer, MD, and colleagues at Johns Hopkins University in Baltimore Md. concluded that the longer the metastasis-free survival after a radical prostatectomy the longer overall survival in men who experience biochemical recurrence (PSA only recurrence) of their prostate cancer. This conclusion was made from a retrospectively study of 450 men [...]
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). [...]
Xgeva (denosumab), which has already been approved by the Food and Drug Administration (FDA) for the prevention fractures in men with advanced prostate cancer that has already migrated to the bone, has been rejected by the FDA to expand the use of the drug to delay the spread of tumors in men without metastases to [...]
Denosumab (Xgeva), the recently approved and only therapy that prolongs bone metastasis-free survival in men with non-metastatic castrate-resistant prostate cancer (CRPC) who are at high risk for the spread of prostate cancer metastasis to bone seems to work best in men with very rapid prostate specific antigen (PSA) kinetics. The large 1,432 man, placebo controlled, [...]
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 [...]
The use of denosumab (Xgeva) as an alternative to the more commonly prescribed zoledronic acid (Zometa) to slow down the development of bone metastases in men with advanced prostate cancer is becoming more common. The most common concern for men taking Zometa and now Xgeva has been osteonecrosis of the jaw. Osteonecrosis of the jaw [...]
Amgen announced that they have published the results from their Phase 3 trial (the '147 study) that evaluated XGEVA® (denosumab) for use in preventing or delaying the onset of bone metastases in men with non-metastatic castration-resistant prostate cancer (CRPC). The results were published in The Lancet. The study found XGEVA significantly prolonged bone metastasis-free survival, [...]
At the recent European Multidisciplinary Cancer Congress in Stockholm, Dr Chris Parker from The Royal Marsden Hospital presented results of the phase 3 ALSYMPCA trial that showed both delayed time to first skeletal-related event (SRE) AND an overall survival (OS) benefit for those men with advanced prostate cancer taking radium-223 (Alpharadin). The real significance of [...]
Amgen (NASDAQ: AMGN) today published a press release that said the U.S. Food and Drug Administration (FDA) will target an action date of April 26, 2012 for the supplemental Biologics License Application (sBLA) (approval) to expand the indication for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer with the goal of reducing the risk [...]
Amgen has submitted a supplemental Biologics License Application (sBLA) to the FDA to expand the indication for denosumab (XGEVA) its RANK ligand inhibitor to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. Although some doctors have already begun to use Xgeva in men with advanced prostate cancer, it is [...]
