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Mylotarg Returns: US FDA Approves Pfizer's Leukemia Drug With Bonus Pediatric Indication

Executive Summary

Agency's Oncologic Drugs Advisory Committee had only discussed gemtuzumab as a treatment for adults with acute myeloid leukemia at its July meeting, but labeling includes a pediatric claim based on a 29-patient trial; drug returns to the US market after being withdrawn in 2010 for failure to confirm clinical benefit.

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