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`2004 > FDA Approves New Indication for Taxotere Prostate Cancer
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`FDA NEWS RELEASE
`FOR IMMEDIATE RELEASE
`P0455
`May 19, 2004
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`FDA Approves New Indication for Taxotere Prostate Cancer
`Today the Food and Drug Administration (FDA) approved Taxotere (docetaxel), injection in combination 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 not
`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, multicenter 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 the 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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`2004 > FDA Approves New Indication for Taxotere Prostate Cancer
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