Xgeva, also known as denosumab, is an injectable medication (injected once a month subcutaneously under the skin in the doctor’s office) that is used to prevent bone fractures and spinal cord compression caused by bone metastases in breast and prostate cancer survivors. Solid tumors in the bone, which is a common site for individuals with [...]
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). [...]
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 [...]
Yesterday, Amgen announced that it had submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand its license for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If approved, XGEVA would be the first therapy licensed to prevent or [...]