Janssen/J&J's abiraterone significantly improved overall survival for advanced prostate cancer patients; but how to use it?

Johnson & Johnson (NYSE: JNJ) affiliate Janssen Pharmaceutica says that results from a pre-specified interim analysis of a randomized, placebo-controlled Phase III study, COU-AA-301, demonstrate that patients treated with the investigational agent abiraterone acetate plus low-dose prednisone/prednisolone showed a significant improvement in overall survival compared to patients treated with prednisone/prednisolone plus placebo.

The company plans to file marketing applications for abiraterone with regulatory authorities in the USA and Europe by the end of the year. Applications in the rest of the world will follow, according to local regulatory requirements. If approved, abiraterone acetate will be commercialized and distributed by another J&J unit, Centocor Ortho Biotech, in the USA and by Janssen in all other countries around the world. J&J acquired the drug along with its $878 million by of Cougar Biotechnology in 2009, and analysts suggest that abiraterone could generate sales approaching the $500 million level a year.

This study, which was presented at the 35th Annual European Society for Medical Oncology (ESMO) Congress in Milan, Italy, included 1,195 patients with metastatic advanced prostate cancer (also referred to as castration-resistant prostate cancer, or CRPC) previously treated with one or two chemotherapy regimens, at least one of which contained docetaxel.