FDA grants fast track designation to agent for metastatic PCa

September 8, 2011

Radium-223 chloride, an investigational alpha-pharmaceutical, has been granted fast track designation by the FDA for the treatment of castration-resistant prostate cancer in patients with bone metastases.

Radium-223 chloride, an investigational alpha-pharmaceutical, has been granted fast track designation by the FDA for the treatment of castration-resistant prostate cancer in patients with bone metastases.

In June 2011, a phase III trial evaluating radium-233 chloride for treating symptomatic bone metastases in castration-resistant prostate cancer patients met its primary endpoint by significantly improving overall survival. The trial was stopped early based on this positive result and a recommendation from the Independent Data Monitoring Committee, following a pre-planned interim analysis.

The safety and tolerability of radium-223 chloride were consistent with previous phase I and phase II trial outcomes and did not show any new or unexpected changes in its safety profile, according to Bayer HealthCare Pharmaceuticals, which exclusively licenses the agent from Algeta ASA. The complete results from the study will be presented at an upcoming scientific meeting.