FDA Expands Gemtuzumab Ozogamicin Approval for Pediatric Patients With AML

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The FDA expanded the approval of gemtuzumab ozogamicin (Mylotarg) to include newly diagnosed pediatric patients (1 month or older) with CD33-positive acute myeloid leukemia (AML).

The FDA expanded the approval of gemtuzumab ozogamicin (Mylotarg) to include newly diagnosed pediatric patients (1 month or older) with CD33-positive acute myeloid leukemia (AML).

The approval is based off data from the multicenter, randomized AAML0531 trial (NCT00372593), which included 1,063 patients between the ages of 0 and 29 with newly diagnosed AML. Participants were randomized to either a 5-cycle chemotherapy regimen or that same chemotherapy regimen plus 3mg/m2 of gemtuzumab ozogamicin one daily on day 6 in induction 1 and once daily on day 7 in intensification 2.

The primary outcome of the study was event-free survival (EFS), which was measured from the date that patients entered the trial until induction failure, relapse, or death. An estimated 48% of patients on the gemtuzumab ozogamicin arm did not experience induction failure, relapse, or death at 5 years, compared to 40% in the chemotherapy arm. However, there was no difference between the 2 arms when it came to overall survival.

Common severe (grade 3 or higher; occurring in 5% or more of patients on the trial) adverse events with gemtuzumab ozogamicin that happened during induction 1 and intensification 2 were infection, febrile neutropenia, decreased appetite, hyperglycemia, mucositis, hypoxia, hemorrhage, increased transaminase, diarrhea, nausea, and hypotension.

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