Pfizer To Pull Mylotarg From U.S. Market

Following discussions with the FDA, Pfizer will discontinue commercial availability of Mylotarg (gemtuzumab ozogamicin for Injection) for the treatment of relapsed acute myeloid leukemia (AML).

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Following discussions with the FDA, Pfizer will discontinue commercial availability of Mylotarg (gemtuzumab ozogamicin for Injection) for the treatment of relapsed acute myeloid leukemia (AML). Pfizer will also withdraw its NDA for Mylotarg effective October 15, 2010. Mylotarg was granted approval under the FDA’s accelerated approval regulations based on overall response rate in three studies, with the required submission of additional data to confirm clinical benefit. The required post...

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