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FDA Expands Gemtuzumab Ozogamicin Approval for Pediatric Patients With AML

Tuesday, June 16, 2020
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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