"Globally, prostate cancer, the fifth most common cancer overall, is a significant public health problem," said Howard I. Scher, MD, Memorial Sloan-Kettering Cancer Center, one of the lead COU-AA-301 investigators.  "These results are important because men with progressive metastatic, castration-resistant prostate cancer often have a poor prognosis and currently have few treatment options."  

A program that provides early access to abiraterone acetate for eligible patients is expected to be opened in the U.S. in October and will be opened in sites outside the U.S. in the following months, with the timing of the program contingent on local health authority and ethics committee approvals.  

"The results of this abiraterone acetate Phase 3 study in patients with metastatic advanced prostate cancer bring us closer to achieving our goal of developing extraordinary preventive, diagnostic and therapeutic solutions based on our tumor microenvironment strategy," said William N. Hait, MD, PhD, Global Therapeutic Head, Oncology, Ortho Biotech Oncology Research & Development.  "We believe that abiraterone acetate is an important medical advance, and we look forward to further developing oncology therapeutic options that may impact patients' lives."  

Ortho Biotech Oncology Research & Development, a unit of Cougar Biotechnology, Inc., previously announced that the Independent Data Monitoring Committee recommended unblinding this Phase 3 study after a pre-specified interim analysis demonstrated a statistically significant improvement in median overall survival and an acceptable safety profile.  The IDMC also recommended that patients in the prednisone/prednisolone plus placebo group be offered treatment with abiraterone acetate.

SOURCE Ortho Biotech Oncology Research & Development