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Pfizer Prepares for Voluntary Withdrawal of U.S. New Drug Application and for Discontinuation of Commercial Availability of Mylotarg®
Date:6/21/2010

NEW YORK, June 21 /PRNewswire-FirstCall/ -- Pfizer Inc. (NYSE: PFE) announced today that based on discussions with the U.S. Food and Drug Administration (FDA), it will be discontinuing commercial availability of Mylotarg® (gemtuzumab ozogamicin for Injection) (used for the treatment of relapsed acute myeloid leukemia (AML)) in the United States and that it will be voluntarily withdrawing the new drug application (NDA) for Mylotarg effective October 15, 2010.

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The approval of single agent Mylotarg in the U.S. was granted under FDA's accelerated approval regulations based on overall response rate in three non-comparative studies and required submission of additional data to confirm clinical benefit.  The required post-approval study (SWOG S0106) combining chemotherapy and Mylotarg did not demonstrate improved survival compared with chemotherapy alone in patients with previously untreated AML.

Additionally, among all patients evaluable for early toxicity the fatal indu
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