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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

e Reactions

The most common adverse reactions (greater than or equal to 5%) reported in clinical trials were joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia and upper respiratory tract infection.

Drug Interactions

ZYTIGA™ is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6.  Avoid co-administration with CYP2D6 substrates that have a narrow therapeutic index.  If an alternative cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate.  Additionally, abiraterone is a substrate of CYP3A4 in vitro.  Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution.

About Metastatic Castration-Resistant Prostate Cancer

Metastatic castration-resistant prostate cancer, or CRPC, occurs when cancer has metastasized beyond the prostate and disease progresses despite serum testosterone below castrate levels.  

The prostate is a gland located around the urethra (under the bladder) in men that produces part of the seminal fluid.  In some cases, cancer of the prostate can grow slowly compared with other cancers.  However, depending on factors including characteristics specific to the patient and the tumor, prostate cancer also can grow very quickly and spread widely.

Excluding skin cancer, prostate cancer is the most frequently diagnosed cancer in men in the United States.  In 2010, more than 217,000 new cases of prostate cancer were estimated and more than 32,000 men died from the disease.

About ZYTIGA (abiraterone acetate)

ZYTIGA (abiraterone acetate) was developed by Ortho Biotech Oncology Research & Development, unit of Cougar Biotechnology, Inc., and is marketed by Centocor Ortho Biotech Inc.  Marketing applications for ZYT
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SOURCE Centocor Ortho Biotech Inc.
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