The FDA made its decision after new clinical data showed that the drug, Alpharadin, improved overall survival in patients with castration-resistant prostate cancer and symptomatic bone metastases. About 90 percent of men with CRPC have radiological evidence of bone metastases, the main cause of disability and death in patients with this kind of cancer.
The trial was so successful that it was stopped early, Bayer said:
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).
Bayer and Algeta signed an agreement in Sept. 2009 to develop the drug, officially radium-223 chloride. Under that contract, Bayer will develop, gain approval and commercialize Alpharadin worldwide, with Algeta receiving up to 50 percent of the profits in the United States.
The companies believe the billion-dollar drug will be ready by mid-2012, ahead of schedule.
This post was originally published on Smartplanet.com