The big news from yesterday is that the Food and Drug Administration (FDA) has approved a MRI-guided, focused ultrasound therapy for the treatment of bone pain associated with metastatic advanced prostate cancer. In a media release written by InSight, an Israeli company states that its ExAblate® MRI-guided, focused ultrasound technology is indicated to treat pain [...]
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 [...]
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 [...]
One of the major causes of prostate cancer morbidity and mortality is bone metastases. Currently, when it comes to treating prostate cancer metastases we are very limited in effective therapies that actually prolong survival. Kirschenbaum A, etal (Departments of Urology and Medicine Division of Pulmonary Diseases Division of Endocrinology, Metabolism, and Bone Diseases, Mount Sinai [...]
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, [...]