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 [...]