NDA submitted for agent that targets metastatic prostate Ca

Centocor Ortho Biotech Inc. has submitted a new drug application to the FDA for the investigational drug abiraterone acetate administered with prednisone for the treatment of metastatic advanced prostate cancer in patients who have received prior chemotherapy containing a taxane.

The application follows completion of a phase III, randomized, double-blind, placebo-controlled clinical study, which evaluated overall survival and tolerability in patients with metastatic advanced prostate cancer treated with abiraterone plus prednisone compared with treatment with placebo plus prednisone. Data from this multicenter study, which included 1,195 patients from 13 countries, were presented at the 2010 European Society for Medical Oncology annual congress in Milan, Italy. (For details on these study findings, see http://www.urologytimes.com/abirateronedata.)

If approved, abiraterone acetate will be commercialized and distributed by Centocor Ortho Biotech Inc. in the U.S. and by Janssen Pharmaceutical Companies outside the U.S.