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`Press Announcements > FDA Approves New Treatment for Advanced Prostate Cancer
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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
`
`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.
`
`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.
`
`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.
`
`“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.”
`
`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 tim:
`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.
`
`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), an<
`renal failure.
`
`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.
`
`Jevtana is marketed by Bridgewater, N.J.—based Sanofi—Aventis.
`For more information:
`
`- FDA: Office of Oncology Drug Products12
`
`- CDC: Informed Decision Making About Prostate Cancer13
`
`- NCI: Prostate Cancer14
`
`#
`
`http://www.fda.gov/N ewsEventsIN ewsroomIPressAnnouncem ents/ucm 216143.htm
`
`AVENTIS EXHIBIT 2059
`Mylan v. Aventis, IPR2016-00712
`
`
`
`5/23/2016
`
`Press Announcements > FDA Approves New Treatment for Advanced Prostate Cancer
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