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`FDA NEWS RELEASE
`For Immediate Release: Dec. 10, 2012
`Media Inquiries: Stephanie Yao, 3017960394, stephanie.yao@fda.hhs.gov
`Consumer Inquiries: 888INFOFDA
`FDA expands Zytiga’s use for latestage prostate cancer
`Drug can now be used before treatment with chemotherapy
`The U.S. Food and Drug Administration today expanded the approved use of Zytiga (abiraterone acetate)
`to treat men with latestage (metastatic) castrationresistant prostate cancer prior to receiving
`chemotherapy.
`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 the production of male sex
`hormone testosterone.
`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 castrationresistant prostate
`cancer, meaning the prostate cancer cells continue to grow even with low levels of testosterone.
`“Today’s approval demonstrates the benefit of further evaluating a drug in an earlier disease setting 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.
`The FDA reviewed Zytiga’s application for this new indication under the agency’s priority review program.
`The program provides for an expedited sixmonth review for drugs that may offer major advances in
`treatment or provide a treatment when no adequate therapy exists.
`Zytiga’s safety and effectiveness for its expanded use were established in a clinical study of 1,088 men
`with latestage, castrationresistant prostate cancer who had not previously received chemotherapy.
`Participants received either Zytiga or a placebo (sugar pill) in combination with prednisone.
`The study was designed to measure the length of time a patient lived before death (overall survival) and
`the length of time a patient lived without further tumor growth as assessed by imaging studies
`(radiographic progressionfree survival, or rPFS).
`Patients 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 with Zytiga at the time of
`analysis.
`The most common side effects reported in those receiving Zytiga include fatigue, joint swelling or
`discomfort, swelling caused by fluid retention, hot flush, diarrhea, vomiting, cough, high blood pressure,
`shortness of breath, urinary tract infection, and bruising.
`The most common laboratory abnormalities included low red blood cell count; high levels of the enzyme
`alkaline phosphatase, which can be a sign of other 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.
`Zytiga is marketed by Horsham, Pa.based Janssen Biotech Inc.
`For more information:
`
`7/23/2015
`
`Press Announcements > FDA expands Zytiga’s use for latestage prostate cancer
`
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm331492.htm
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`FDA approves Zytiga for latestage prostate cancer (April 2011)11
`FDA: Office of Hematology and Oncology Products12
`FDA: Approved Drugs: Questions and Answers13
`NCI: Prostate Cancer14
`
`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.
`
`The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health
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