A new statement by Janssen Research & Development, LLC informs that they have unblinded the Phase 3 study, COU-AA-302, which shows that Zytiga (abiraterone acetate), when taken alongside prednisone, is effective in treating mildly symptomatic or asymptomatic patients who are suffering from metastatic castration-resistant prostate cancer (CRPC) and have not gone through chemotherapy.
Regarding Zytiga, which was approved by the U.S Food and Drug Administration (FDA) in 2011, William N. Hait, MD, PhD, from Global Head, Janssen R&D commented:
“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.”
COU-AA-302, which is a double-blind, randomized, international, placebo-controlled study, involved 1,088 volunteers who were given either Zytiga 1,000 mg once a day, as well as prednisone 5mg twice a day, or a prednisone 5mg twice a day, as well as a placebo.
It was recommended by The Independent Data Monitoring Committee (IDMC) that the study be unblinded after analyzing the evidence – comparing the overall survival rates with the people who took the Zytiga and prednisone, compared with the rates of the patients who took the placebo. The IDMC added that the patients who took the placebo should now be treated with Zytiga.
The results from the study will be shown at a medical meeting in the near future, and will be published in a peer-reviewed journal.
“The COU-AA-302 study has been a key priority for us as we expand our understanding of the utility of Zytiga in metastatic prostate cancer. We’re delighted that these data will soon be added to the growing body of literature about this important medication.”
Written By Christine Kearney