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`FDA NEWS RELEASE
`For Immediate Release: June 17, 2010
`Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
`Consumer Inquiries: 888-INFO-FDA
`FDA Approves New Treatment for Advanced Prostate Cancer
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`The U.S. Food and Drug Administration today approved Jevtana (cabazitaxel), a chemotherapy drug used in combination with the steroid prednisone to treat men with prostate
`cancer. Jevtana is the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, a commonly used drug for
`advanced prostate cancer.
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`In prostate cancer, the male sex hormone testosterone can cause prostate tumors to grow. Drugs, surgery, or other hormones are used to reduce testosterone production or to
`block it. Some men have hormone refractory prostate cancer, meaning the prostate cancer cells continue to grow, despite testosterone suppression. Different treatments are
`needed for men with this type of cancer.
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`Jevtana was reviewed under the FDA’s priority review program, which 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. Jevtana received approval ahead of the product’s Sept. 30, 2010, goal date.
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` “Patients have few therapeutic options in this disease setting,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products, part of the FDA’s Center for Drug
`Evaluation and Research. “FDA was able to review and approve the application for Jevtana in 11 weeks, expediting the availability of this drug to men with prostate cancer.”
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`Jevtana’s safety and effectiveness was established in a single, 755-patient study. All study participants had previously received docetaxel. The study was designed to measure
`overall survival (the length of time before death) in men who received Jevtana in combination with prednisone compared with those who received the chemotherapy drug,
`mitoxantrone, in combination with prednisone. The median overall survival for patients receiving the Jevtana regimen was 15.1 months compared with 12.7 months for those who
`received the mitoxantrone regimen.
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`Side effects in those treated with Jevtana included decrease in infection-fighting white blood cells (neutropenia), anemia, decrease in the number of white blood cells (leukopenia),
`low level of platelets in the blood (thrombocytopenia), diarrhea, fatigue, nausea, vomiting, constipation, weakness (asthenia), and renal failure.
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`Prostate cancer, which usually occurs in older men, is the second most common cancer among men in the United States, behind skin cancer. In 2006, the most recent year for
`which numbers were available, 203,415 men developed prostate cancer and 28,372 men died from the disease, according to the Centers for Disease Control and Prevention.
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`Jevtana is marketed by Bridgewater, N.J.-based Sanofi-Aventis.
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`For more information:
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`FDA: Office of Oncology Drug Products
`CDC: Informed Decision Making About Prostate Cancer
`NCI: Prostate Cancer
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