It has been announced that the application for the FDA approval of abiraterone with prednisone has been submitted by Centocor Ortho Biotech Inc. As I have discussed in prior posts, abiraterone is an extraordinarily promising investigational drug designed to treat metastatic advanced prostate cancer in men who have received prior chemotherapy containing a taxane.
The filing of the application follows completion of a phase III, randomized, double-blind, placebo-controlled clinical study, which evaluated overall survival and tolerability in men with metastatic advanced prostate cancer treated with abiraterone plus prednisone compared with treatment with placebo plus prednisone. The data from this multi-center study, which included 1,195 men from 13 countries, has already been presented at the 2010 European Society for Medical Oncology annual congress in Milan, Italy.
The data was so positive the trial was halted and unblinded prior to the projected completion goals being met. I am hopeful that abiraterone will be approved in the middle of 2011.
Joel T Nowak, M.A., M.S.W.