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Study Unblinded: ZYTIGA® (abiraterone acetate) Plus Prednisone for Asymptomatic or Mildly Symptomatic Chemotherapy-Naive Patients with Metastatic Castration-Resistant Prostate Cancer
Date:3/8/2012

ubmit for regulatory approval in the United States and around the world beginning in the second half of 2012.

The recommendation to unblind a clinical study at an interim analysis is made by an Independent Data Monitoring Committee based on predetermined criteria, such as meeting certain efficacy endpoints and the risk/benefit profile, as well as ethical considerations.  In cases where there is compelling evidence of clinical benefit, the IDMC may also recommend that patients in the placebo arm of the study be crossed over to the active arm.

About ZYTIGA
"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," said Hait.

ZYTIGA in combination with prednisone was approved by the U.S. Food and Drug Administration (FDA) in April 2011 for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.  The Phase 3 study for this initial ZYTIGA indication was also unblinded at the interim point, in August 2010, based on a statistically significant improvement in overall survival and an acceptable safety profile.  A subsequent analysis with more mature data confirmed the survival benefit and safety profile.

Indication
ZYTIGA® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have received prior chemotherapy containing docetaxel.

Important Safety Information

Contraindications - ZYTIGA® (abiraterone acetate) may cause fetal harm (Pregnancy Category X) and is contraindicated in women who are or may become pregnant.

Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess - Use with ca
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SOURCE Janssen Research & Development, LLC
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