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Algeta ASA Announces its Partner Bayer AG Submits Radium-223 Dichloride for European Union Marketing Authorization for Treatment of Castration-Resistant Prostate Cancer with Bone Metastases


Wednesday, 12 Dec 2012 10:17am EST 

Algeta ASA (Algeta) announced that Bayer AG (Bayer) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for radium-223 dichloride (radium-223) for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases. The submission is based on data from the pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial, which was conducted by Algeta. In the study, radium-223 increased overall survival by 44% (HR=0.695, p=0.00007), resulting in a 30.5% reduction in the risk of death compared to placebo. The median overall survival (OS) benefit in patients with radium-223 was 3.6 months, based on 14.9 months OS with radium-223 plus best standard of care (BSoC) vs. 11.3 months with placebo plus BSoC. These updated results were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2012. 

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139.12
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30 Oct 2014