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`Press Announcements > FDA approves Zytiga for latestage prostate cancer
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`U.S. Food and Drug Administration
`Protecting and Promoting Your Health
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`Archived Content
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`FDA NEWS RELEASE
`For Immediate Release: April 28, 2011
`Media Inquiries: Erica Jefferson, 3017964988, erica.jefferson@fda.hhs.gov
`(mailto:erica.jefferson@fda.hhs.gov)
`Consumer Inquiries: 888INFOFDA
`
`FDA approves Zytiga for latestage prostate cancer
`
`The U.S. Food and Drug Administration today approved Zytiga (abiraterone acetate) in combination with prednisone
`(a steroid) to treat patients with latestage (metastatic) castrationresistant prostate cancer who have received prior
`docetaxel (chemotherapy).
`
`In prostate cancer, the male sex hormone testosterone stimulates prostate tumors to grow. Drugs or surgery are used
`to reduce testosterone production or to block testosterone’s effects. However, sometimes prostate cancer can
`continue to grow even when testosterone levels are low. Men with these cancers are said to have castrationresistant
`prostate cancer.
`
`Zytiga is a pill that targets a protein called cytochrome P450 17A1 (CYP17A1) which plays an important role in the
`production of testosterone. The drug works by decreasing the production of this hormone that would stimulate cancer
`cells to continue growing.
`
`The application was reviewed under the FDA’s priority review program, which 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 is being approved ahead of the product’s June 20, 2011 regulatory goal date.
`
`“Zytiga prolonged the lives of men with latestage prostate cancer who had received prior treatments and had few
`available therapeutic options,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the
`FDA’s Center for Drug Evaluation and Research.
`
`Zytiga’s safety and effectiveness were established in a clinical study of 1,195 patients with latestage castration
`resistant prostate cancer who had received prior treatment with docetaxel chemotherapy. Patients received either
`Zytiga once daily in combination with prednisone two times a day or a placebo (sugar pill) twice daily in combination
`with prednisone.
`
`The study was designed to measure overall survival, the length of time from when the treatment started until a
`patient's death. Patients who received the Zytiga and prednisone combination had a median overall survival of 14.8
`months compared to 10.9 months for patients receiving the placebo and prednisone combination.
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`Press Announcements > FDA approves Zytiga for latestage prostate cancer
`
`The most commonly reported side effects in patients receiving Zytiga included joint swelling or discomfort, low levels
`of potassium in the blood, fluid retention (usually of the legs and feet), muscle discomfort, hot flashes, diarrhea,
`urinary tract infection, cough, high blood pressure, heartbeat disorders, urinary frequency, increased nighttime
`urination, upset stomach or indigestion and upper respiratory tract infection.
`
`Zytiga is marketed by Horsham, Pa.based Centocor Ortho Biotech, Inc.
`
`For more information:
`
`FDA: Office of Oncology Drug Products
`(/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm091745.htm)
`
`
`FDA: Approved Drugs: Questions and Answers (/Drugs/ResourcesForYou/Consumers/ucm054420.htm)
`
`
`NCI: Prostate Cancer (http://www.cancer.gov/cancertopics/types/prostate)
`
`
`The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by
`assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products
`for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food
`supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
`
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