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, [...]