Radium Ra 223 Dichloride Recommended for Approval in EU
News Sep 23, 2013
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.”
High Fruit and Veg Consumption May Reduce Breast Cancer RiskNews
Women who eat a high amount of fruits and vegetables each day may have a lower risk of breast cancer, especially of aggressive tumors, than those who eat fewer fruits and vegetables, according to a new study led by researchers from Harvard T.H. Chan School of Public Health.READ MORE
Kidney Cancer Driver Could Lead to New Treatment StrategyNews
Scientists have uncovered a potential therapeutic target for kidney cancers that have a common genetic change. Scientists have known this genetic change can lead to an overabundance of blood vessels, which help feed nutrients to the tumors. Their latest finding shows a potential new cancer-driving pathway.READ MORE
Why Might Super-Tasters be at Higher Cancer Risk?News
High bitter-taste sensitivity is associated with a significantly increased risk of cancer in older British women, according to researchers who conducted a unique study of 5,500 women whose diet, lifestyle and health has been tracked for about 20 years.READ MORE
International Conference on Neurooncology and Neurosurgery
Sep 17 - Sep 18, 2018