9/1/2015
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`2004 > FDA Approves New Indication for Taxotere -- Prostate Cancer
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`FDA NEWS RELEASE
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`FOR IMMEDIATE RELEASE
`P04-55
`May 19, 2004
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`FDA
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`FDA Approves New Indication for Taxotere -- Prostate Cancer
`
`Today the Food and Drug Administration (FDA) approved Taxotere (docetaxel), injection in combinatior
`with prednisone ( a steroid), for the treatment of patients with advanced metastatic prostate cancer.
`This is the first drug approved for hormone refractory prostate cancer that has shown a survival
`benefit.
`
`“We consider this approval an important advance in the treatment of prostate cancer because it can
`help some patients live longer. Patients need as many effective treatment options as possible and
`Taxotere, in combination with prednisone, offers hope to certain patients who have not responded to
`other treatments,” said Dr. Lester M. Crawford, Acting FDA Commissioner.
`
`Prostate cancer is the second leading cause of cancer death in men and for those patients who have nc
`responded to hormone therapy, Taxotere, in combination with prednisone, is a new treatment option
`that has now shown a survival advantage.
`
`Taxotere works by inhibiting tubulin, a protein essential to cell division, thus preventing cancer cells
`from dividing and growing in number.
`
`The safety and effectivness of Taxotere was established in a randomized, multi-center global clinical
`trial with over 1,000 patients comparing chemotherapy with taxotere and prednisone to mitoxantrone
`and prednisone in men with metastatic, hormone—refractory prostate cancer. Taxotere, in combination
`with prednisone, given every three weeks showed a survival advantage of approximately 2.5 months
`over the control group in the trial.
`
`The most common adverse events reported were nausea, alopecia (hair loss), and bone marrow
`suppression. In addition, fluid retention and peripheral neuropathy (tingling sensations in the
`extremities), known effects of taxotere, were also observed.
`
`The American Cancer Society estimates there will be about 230,900 new cases of prostate cancer in th
`United States in 2004. About 29,900 men will die of this disease this year alone.
`
`Taxotere is distributed by Aventis Pharmaceuticals Inc. of Bridgewater, NJ.
`#
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`9/1/2015
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`2004 > FDA Approves New Indication for Taxotere -- Prostate Cancer
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