German drug major Bayer (BAYN: DE) has announced positive results of a Phase III study of its drug radium 223 dichloride in castration-resistant prostate cancer (CRPC) patients with symptomatic bone metastases, which are published in today’s issue of the New England Journal of Medicine. These data supported the US Food and Drug Administration approval of radium 223, under the brand name Xofigo, in May ( The Pharma Letter May 16).
In the ALSYMPCA study, radium 223 reduced the risk of death by 30.5% compared to placebo, a significant risk reduction (HR=0.695). This overall survival benefit was observed in patients who were treated with the chemotherapy docetaxel prior to study enrollment and in those who were not. All patients in the study were treated with best standard of care in addition to radium 223 or placebo.
Christopher Parker, consultant in clinical oncology at The Royal Marsden Hospital and The Institute of Cancer Research, London, and principal investigator of ALSYMPCA, said: "The quality of life and overall survival benefits observed with radium 223 represent real progress for patients, as bone metastases can be painful and lead to death in men with CRPC. These data showing significantly improved overall survival, regardless of prior treatment with chemotherapy, add to our knowledge about the potential use and benefit of radium 223 in these patients."
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