Bayer has filed its eagerly-anticipated prostate cancer drug Alpharadin, developed by Algeta, for approval in Europe.
The German group has submitted a marketing authorisation application to the European Medicines Agency for Alpharadin, the first in a new class of 'alpha-pharmaceuticals' which is based on radium-223. Specifically, it is for the treatment of castration-resistant prostate cancer patients with bone metastases.
The submission is based on data from the Phase III ALSYMPCA trial which showed that Alpharadin significantly increased overall survival by 44%, resulting in a 30.5% reduction in the risk of death compared to placebo. The median overall survival benefit in patients with radium-223 was 3.6 months based on 14.9 months OS with the drug plus best standard of care, versus 11.3 months with placebo plus BSoC.
Kemal Malik, head of global development at Bayer, noted that "with its novel mode of action and the proven survival benefit, radium-223 represents an innovation in the treatment of prostate cancer and is an important example of our growing oncology portfolio". The filing has triggered a 50 million euro to Algeta.
Andrew Kay, the Norwegian firm's chief executive, noted that this submission "also brings us another step closer to the royalties we are due from the launch of the product in Europe. Meanwhile, we look forward to the initiation of new trials evaluating the broader clinical potential of radium-223 for treating cancer patients with bone metastases".