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, [...]
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 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. If approved, denosumab would be the first therapy licensed to prevent or delay the spread of cancer [...]
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 [...]
To evaluate the effects of timing and length of zoledronic acid (ZA) treatment on outcomes for men with prostate cancer, researchers from the University of Illinois at Chicago and the Hind T. Hatoum & Company, Chicago, IL. evaluated a large contingent of men who had been diagnosed with prostate cancer from January 2003 to October [...]
According to the FDA approval label, zoledronic acid (Zometa) should be administered to men with advanced prostate cancer once they have failed one hormone therapy type, in other words, once the cancer has become castrate resistant. Researchers at the Centre Hospitalier de i’Université de Montréal, Hôpital Notre-Dame, Montréal, Quebec, Canada evaluated the effect of zoledronic [...]
