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FDA Expands Wyeth's Mylotarg Indication to Pediatric Patients With CD33-Positive AML

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.

In the combination treatment arm, 48 percent of patients didn't experience induction failure, relapse, or death at five years, compared to 40 percent in the chemo-only arm. The approval was based on this event-free survival advantage, even though there was no difference between the two arms in overall survival. The most common grade 3 or higher adverse events in those receiving gemtuzumab ozogamicin were infection, febrile neutropenia, decreased appetite, and hyperglycemia.