In one of those situations when actual clinical practice precedes the normal drug development process a recent announcement from Janssen Research & Development, LLC (Johnson & Johnson) informs that they have un-blinded their Phase 3 study, COU-AA-302, which clearly demonstrates that Zytiga (abiraterone acetate), when taken with prednisone, is effective in treating both mildly symptomatic or asymptomatic men who have metastatic castration-resistant prostate cancer (CRPC) and have not yet had chemotherapy.
The U.S Food and Drug Administration (FDA) approved Zytiga in 2011 for men post chemotherapy failure. According to William N. Hait, MD, PhD, from Global Head, Janssen R&D,
“Since its first approval in the U.S in 2011, Zytiga has been approved in 39 additional countries, many thousands of men have received treatment with it, and it is quickly becoming one of the cornerstones of our oncology offerings.”
The trial, COU-AA-302 which is a double-blind, randomized, international, placebo-controlled study, involved 1,088 men who were given either Zytiga at a dosage of 1,000 mg once a day, as well as prednisone at