Chicago, IL (June 3, 2011) – Data related to ZYTIGA™ (abiraterone acetate) will be presented at the 2011 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The studies were sponsored by Ortho Biotech Oncology Research & Development, unit of Cougar Biotechnology, Inc.
“We are pleased that these data have been selected for presentation at the 2011 ASCO Annual Meeting,” said William N. Hait, M.D., Ph.D., Global Therapeutic Area Head, Ortho Biotech Oncology Research & Development, unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C. “We are committed to advancing scientific dialogue and understanding around our clinical studies in areas such as metastatic castration-resistant prostate cancer.”
ZYTIGA was approved by the U.S. Food and Drug Administration on April 28, 2011 and is marketed in the United States by Centocor Ortho Biotech Inc.
Data from the following studies have been selected for presentation:
Evaluation of circulating tumor cell (CTC) enumeration as an efficacy response biomarker of overall survival (OS) in metastatic castration-resistant prostate cancer (mCRPC): Planned final analysis (FA) of COU-AA-301, a randomized double-blind, placebo-controlled phase III study of abiraterone acetate (AA) plus low-dose prednisone (P) post docetaxel. (Abstract LBA4517)
Oral Abstract Session, Monday June 6, 1:30 to 1:45 p.m., Hall D1Authors: H. I. Scher, G. Heller, A. Molina, T. S. Kheoh, G. Attard, J. Moreira, S. K. Sandhu, C. Parker, C. Logothetis, R. T. McCormack, K. Fizazi, A. Anand, D. C. Danila, M. Fleisher, D. Olmos, C. M. Haqq, J. S. De Bono; Memorial Sloan-Kettering Cancer Center, New York, NY; Ortho Biotech Oncology Research & Development, Los Angeles, CA; The Institute for Cancer Research and Royal Marsden Hospital, Sutton, United Kingdom; University of Texas M. D. Anderson Cancer Center, Houston, TX; Veridex LLC, Raritan, NJ; Institut Gustave Roussy, Villejuif, France
Effect of abiraterone acetate (AA) on pain control and skeletal-related events (SRE) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) post docetaxel (D): Results from the COU-AA-301 phase III study. (Abstract 4520)
Oral Abstract Session, Monday June 6, 3:15 to 3:30 p.m., Hall D1
Authors: C. Logothetis, J. S. De Bono, A. Molina, E. M. Basch, K. Fizazi, S. A. North, K. N. Chi, R. J. Jones, O. B. Goodman, P. N. Mainwaring, C. N. Sternberg, D. D. Gagnon, R. Dhawan, M. Rothman, Y. Hao, C. S. Liu, T. S. Kheoh, H. I. Scher, C. M. Haqq; University of Texas M. D. Anderson Cancer Center, Houston, TX; The Institute for Cancer Research and Royal Marsden Hospital, Sutton, United Kingdom; Ortho Biotech Oncology Research & Development, Los Angeles, CA; Memorial Sloan-Kettering Cancer Center, New York, NY; Institut Gustave Roussy, Villejuif, France; Cross Cancer Institute, Edmonton, AB, Canada; British Columbia Cancer Agency, Vancouver, BC, Canada; Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom; Nevada Cancer Institute Medical Group, Las Vegas, NV; Mater Misericordiae Adult Hospital, South Brisbane, Australia; San Camillo-Forlanini Hospital, Rome, Italy; Thomson Reuters, Santa Barbara, CA; Johnson & Johnson, Raritan, NJ; Johnson & Johnson Pharmaceutical Services, Raritan, NJ; Cougar Biotechnology Inc., Raritan, NJ
About ZYTIGA (abiraterone acetate)
ZYTIGA (abiraterone acetate) is the first oral, once-daily medication indicated for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel. ZYTIGA was developed by Ortho Biotech Oncology Research & Development, unit of Cougar Biotechnology, Inc., and is marketed by Centocor Ortho Biotech Inc. in the United States. For more information about ZYTIGA, visit www.ZYTIGA.com.
Marketing applications for ZYTIGA have been filed with other regulatory authorities throughout the world.
About Circulating Tumor Cells
Circulating tumor cells (CTC) are cancer cells that have detached from the tumor and are found at extremely low levels in the bloodstream. The value of capturing and counting CTCs is evolving as more research data is gathered about the utility of these markers in monitoring disease progression and potentially guiding personalized cancer therapy. The CTC test used in the COU-AA-301 study was CELLSEARCH®, the first and only regulatory-cleared in vitro diagnostic test to capture and count CTCs to determine the prognosis of patients with metastatic breast, colorectal or prostate cancer. The test can be administered at any time during the course of therapy as a routine blood test. It is used in combination with other tests and a clinician’s assessment, to provide a more complete picture of a patient’s prognosis. CELLSEARCH is manufactured and marketed by Veridex, LLC.
Important Safety Information
Contraindications
ZYTIGA™ may cause fetal harm (Pregnancy Category X) and is contraindicated in women who are or may become pregnant.
Warnings and Precautions
Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess
Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in hypertension, hypokalemia and fluid retention. Safety has not been established in patients with LVEF < 50% or NYHA Class III or IV heart failure. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly.
Adrenocortical Insufficiency (AI) has been reported in clinical trials after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn or if the patient experiences unusual stress. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during and after stressful situations.
Hepatotoxicity - Increases in liver enzymes have led to drug interruption, dose modification and/or discontinuation. Monitor liver function and modify, withhold or discontinue ZYTIGA™ dosing as recommended (See Prescribing Information for more information).
Food Effect - ZYTIGA™ must be taken on an empty stomach. Exposure of abiraterone increases up to 10-fold when abiraterone acetate is taken with meals. No food should be eaten for at least two hours before the dose of ZYTIGA™ is taken and for at least one hour after the dose of ZYTIGA™ is taken.
Adverse 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 the Ortho Biotech Oncology Research & Development, unit of Cougar Biotechnology, Inc.
Ortho Biotech Oncology Research & Development, unit of Cougar Biotechnology, Inc., partners with affiliated units and companies in the Janssen Pharmaceutical Companies, such as Centocor Ortho Biotech Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C., in the research and development of oncology and supportive care treatments.
About Centocor Ortho Biotech Inc.
Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology, urology and oncology. Built upon a pioneering history, Centocor Ortho Biotech Inc. harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options. Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and health care professionals have access to the latest treatment information, support services and quality care. In addition to metastatic castration-resistant prostate cancer, Centocor Ortho Biotech markets oncology treatments for diseases such as recurrent ovarian cancer, relapsed or refractory multiple myeloma, hairy cell leukemia and anemia due to the effect of concomitantly administered chemotherapy. For more information about Centocor Ortho Biotech, visit www.centocororthobiotech.com.
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