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NEW YORK – The US Food and Drug Administration approved an expanded indication for Wyeth Pharmaceuticals' gemtuzumab ozogamicin (Mylotarg) for newly diagnosed pediatric patients at least one-month old who have CD33-positive acute myeloid leukemia.

The agency approved the expanded indication to this pediatric population based on the results of the AAML0531 trial, which involved 1,000 AML patients who were younger than a year old and up to 29 years old. They were randomized to receive either chemotherapy alone or in combination with gemtuzumab ozogamicin.

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