Press Announcements > FDA expands Zytiga’s use for late-stage prostate cancer
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`FDA NEWS RELEASE
`For Immediate Release: Dec. 10, 2012
`Media Inquiries: Stephanie Yao, 301-796-0394
`Consumer Inquiries: 888-INFO-FDA
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`, stephanie.yao@fda.hhs.gov
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`FDA expands Zytiga’s use for late-stage prostate cancer
`Drug can now be used before treatment with chemotherapy
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`The U.S. Food and Drug Administration today expanded the approved use of Zytiga (abiraterone acetate) to treat men with late-stage (metastatic) castration-resistant prostate
`cancer prior to receiving chemotherapy.
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`The FDA initially approved Zytiga in April 2011 for use in patients whose prostate cancer progressed after treatment with docetaxel, a chemotherapy drug. Zytiga is a pill that
`decreases he produc ion of male sex hormone testosterone.
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`In prostate cancer, testosterone stimulates prostate tumors to grow. Drugs or surgery are used to reduce testosterone production or to block testosterone’s effects. Some men have
`castration-resistant prostate cancer, meaning the prostate cancer cells continue to grow even with low levels of testosterone.
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`“Today’s approval demonstrates the benefit of further evaluating a drug in an earlier disease set ing and provides patients and health care providers the option of using Zytiga earlier
`in the course of treatment,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.
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`The FDA reviewed Zytiga’s application for this new indication under the agency’s priority review program. The program provides for an expedited six-month review for drugs that
`may offer major advances in treatment or provide a treatment when no adequate therapy exists.
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`Zytiga’s safety and effec iveness for its expanded use were established in a clinical study of 1,088 men with late-stage, castration-resistant prostate cancer who had not previously
`received chemotherapy. Participants received either Zytiga or a placebo (sugar pill) in combination with prednisone.
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`The study was designed to measure the length of ime a patient lived before death (overall survival) and he length of time a patient lived without further tumor growth as assessed
`by imaging studies (radiographic progression-free survival, or rPFS).
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`Pa ients who received Zytiga had a median overall survival of 35.3 months compared with 30.1 months for those receiving the placebo. Study results also showed Zytiga improved
`rPFS. The median rPFS was 8.3 months in the placebo group and had not yet been reached for patients treated wi h Zytiga at the time of analysis.
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`The most common side effects reported in those receiving Zytiga include fatigue, joint swelling or discomfort, swelling caused by fluid reten ion, hot flush, diarrhea, vomiting, cough,
`high blood pressure, shortness of breath, urinary tract infection, and bruising.
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`The most common laboratory abnormalities included low red blood cell count; high levels of the enzyme alkaline phosphatase, which can be a sign of o her serious medical
`problems; high levels of fatty acids, sugar, and liver enzymes in the blood; and low levels of lymphocytes, phosphorous and potassium in the blood.
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`Zytiga is marketed by Horsham, Pa.-based Janssen Biotech Inc.
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`For more information:
`FDA approves Zytiga for late-stage prostate cancer (April 2011)
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`FDA: Office of Hematology and Oncology Products
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`FDA: Approved Drugs: Questions and Answers
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`NCI: Prostate Cancer
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`This press release was updated on Dec. 10, 2012 at 2:30 p.m. to correct the date when Zytiga was originally approved to April 2011.
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`http://www fda gov/NewsEvents/Newsroom/PressAnnouncements/ucm331492 htm[6/30/2016 12:42:54 PM]
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`Press Announcements > FDA expands Zytiga’s use for late-stage prostate cancer
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`http://www fda gov/NewsEvents/Newsroom/PressAnnouncements/ucm331492 htm[6/30/2016 12:42:54 PM]
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