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Pivotal Phase 3 Study Published in The New England Journal of Medicine (NEJM) Finds Overall Survival of Patients with Metastatic Castration-Resistant Prostate Cancer is Significantly Improved with ZYTIGA™ (abiraterone acetate)
Date:5/25/2011

Marsden NHS Foundation Trust, and lead author.  "The data indicate that abiraterone acetate has the potential to meet a significant unmet need for these patients."

Androgens are hormones that promote the development and maintenance of male sex characteristics.   However, in prostate cancer, androgens can help fuel the tumor's growth.  Androgen production primarily occurs in the testes and adrenal glands; in men with prostate cancer, the tumor tissue is an additional source of androgens. ZYTIGA is an oral androgen biosynthesis inhibitor that works by selectively inhibiting the CYP17 enzyme complex, which is required for the production of androgens at these three sources.

The U.S. Food and Drug Administration (FDA) approved ZYTIGA on April 28, 2011 for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.

The results of this randomized, double-blind, placebo-controlled study were presented in part during a late-breaking presentation at the Presidential Symposium at the 35th Annual European Society for Medical Oncology Congress in Milan, Italy on October 11, 2010, and have been presented at several conferences since then.

Study Design

ZYTIGA, in combination with prednisone, was evaluated in a Phase 3, randomized, placebo-controlled, multicenter clinical study in patients who had received prior chemotherapy containing a taxane (N = 1,195).  A total of 1,195 patients were randomized 2:1 to receive ZYTIGA 1000 milligrams (mg) daily in combination with prednisone 5 mg twice daily or placebo in combination with prednisone 5 mg twice daily (control arm).  The primary endpoint was overall survival.

Indication

ZYTIGA (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) w
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SOURCE Centocor Ortho Biotech Inc.
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