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Pfizer Pulls Mylotarg For Safety 10 Years After Accelerated Approval

Executive Summary

Although Pfizer's voluntary withdrawal of its acute myeloid leukemia therapy Mylotarg is the first complete withdrawal of an accelerated approval NDA, but as in other cases where the confirmatory trial fails to substantiate the initial signs of efficacy that supported the accelerated approval, FDA is not completely closing the door on access to the drug

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