FDA Grants Fast Track Designation to Bayer’s Investigational Compound Alpharadin for the Treatment of Castration Resistant Prostate Cancer in Patients with Bone Metastases

24-Aug-2011 - Germany

Bayer HealthCare announced that its investigational compound Alpharadin^TM (radium-223 chloride), which is exclusively licensed from Algeta ASA, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of castration-resistant (hormone refractory) prostate cancer in patients with bone metastases.

“Prostate cancer is a leading cause of death among men all over the world. There is a significant unmet need for patients suffering from the advanced stages of the disease, especially in patients whose cancer has spread to the bone,” said Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee. “We are excited that Alpharadin has achieved this important milestone and recognize this fast track designation as an important step in the overall development of Alpharadin, particularly for those patients in need of treatment.”

In June, Bayer announced that the Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial evaluating Alpharadin in patients with CRPC and symptomatic bone metastases met its primary endpoint by significantly improving overall survival. Based on a recommendation from the Independent Data Monitoring Committee (IDMC), following a pre-planned interim analysis, the study was stopped and patients on the placebo arm have been offered treatment with Alpharadin. The overall survival result was statistically significant (two-sided p-value = 0.0022, HR = 0.699, the median overall survival was 14.0 months for Alpharadin and 11.2 months for placebo).

The safety and tolerability of Alpharadin were consistent with previous Phase I and Phase II trial outcomes and did not show any new or unexpected changes in the safety profile of Alpharadin. The complete results from the study will be presented at an upcoming scientific meeting.

https://www.bionity.com/en/news/134058/fda-grants-fast-track-designation-to-bayers-investigational-compound-alpharadin-for-the-treatment-of-castration-resistant-prostate-cancer-in-patients-with-bone-metastases.html