Algeta ASA has announced that 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 by Bayer of the MAA for radium-223 with the EMA is a significant landmark for Algeta. It carries us further towards realizing our vision of becoming a world class oncology company bringing novel targeted medicines to cancer patients,” said Andrew Kay, Algeta’s President & CEO.
Kay continued, “I would like to thank the teams at both Algeta and Bayer, which have worked diligently together, for delivering this major accomplishment. Under the terms of our 2009 Agreement, the first complete submission for marketing approval triggers a €50 million milestone payment to Algeta from Bayer. 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.”
“This submission reflects our commitment to developing innovative cancer treatments for patients for whom only limited therapy options are available today,” said Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and Head of Global Development.
Malik continued, “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 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 significantly increased overall survival by 44 percent (HR=0.695, p=0.00007), resulting in a 30.5 percent 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.
The most common hematologic adverse events for patients treated with radium-223 and best standard of care (BSoC) and compared to placebo and BSoC included anemia (31% vs. 31%), neutropenia (5% vs. 1%) and thrombocytopenia (12% vs. 6%).
With respect to Grade 3 and 4 adverse events, the most common events included anemia (13% vs. 13%), neutropenia (2% vs. 1%) and thrombocytopenia (6% vs. 2%).
The most common non-hematologic adverse events in patients treated with radium-223 and BSoC compared to placebo and BSoC included bone pain (50% vs. 62%), nausea (36% vs. 35%), diarrhea (25% vs. 15%) and vomiting (19% vs. 14%).
With respect to Grade 3 to 4 adverse events, the most common events included bone pain (21% vs. 26%).