Xgeva results of '147' trial prevention of bone metastases in Prostate Cancer is published in The Lancet

The'147' Phase III study of Xgeva (denosumab)from Amgen/GSK ) evaluated Xgeva for use in preventing or delaying the onset of bone metastases in men with nonmetastatic castration-resistant prostate cancer and is published in The Lancet. The study found Xgeva significantly prolonged bone metastasis-free survival, delayed time to bone metastasis and reduced the risk of symptomatic bone metastases. This study is the first to demonstrate that targeting the bone microenvironment prevents bone metastasis in men with prostate cancer. The FDA has set April 26, 2012 as the targeted Prescription Drug User Fee Act action date for the sBLA. If approved, Xgeva would be the first-and-only therapy licensed to prevent or delay the spread of cancer to the bone. see "Denosumab and bone-metastasis-free survival in men with castration-resistant prostate cancer: results of a phase 3, randomised, placebo-controlled trial." Prof Matthew R Smith MD, Prof Fred Saad MD, Prof Robert Coleman MD, Neal Shore MD, Prof Karim Fizazi MD, Prof Bertrand Tombal MD and others The Lancet, Early Online Publication, 16 November 2011doi:10.1016/S0140-6736(11)61226-9