Algeta ASA has announced that Bayer has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending radium Ra 223 dichloride (radium-223) for approval with a proposed indication for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
The decision of the European Commission (EC) on the approval is expected in the fourth quarter of 2013.
Radium Ra 223 dichloride was approved by the US Food and Drug Administration (FDA) in May under the brand name Xofigo®.
The CHMP recommendation is based on data from the pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial.
Andrew Kay, Algeta’s President & CEO, said: “Today’s positive opinion from the CHMP marks an important step in the anticipated approval of radium-223 in Europe. This recommendation, soon after Xofigo’s US approval and launch, again highlights the need for a new therapeutic option that has been shown to significantly improve survival in prostate cancer patients whose disease has spread to the bones. We are committed to working with Bayer to ensure patients and physicians in Europe gain access to radium-223 as soon as possible.”
“This recommendation confirms the safety and efficacy of radium-223 as a potential treatment option for patients suffering from castration-resistant prostate cancer with bone metastases, a debilitating and potentially deadly condition,” said Christopher Parker, MD, Principal Investigator of the ALSYMPCA trial and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust, London, and The Institute of Cancer Research, London.
Parker continued, “There are many men with this disease who could potentially benefit from the availability of radium-223 due to its unique ability to extend life and delay symptomatic skeletal events such as spinal cord compression and the need for external beam radiation therapy for bone pain.”