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FDA Approves Gemtuzumab Ozogamicin for Pediatric CD33-Positive AML

By: Jocelyn Solis-Moreira, MS
Posted: Thursday, June 18, 2020

On June 16, the U.S. Food and Drug Administration (FDA) extended the use of the monoclonal antibody gemtuzumab ozogamicin (Mylotarg) to include pediatric patients (1 month or older) with newly diagnosed CD33-positive acute myeloid leukemia (AML).

The FDA approval was based on data from the multicenter AAML0531 clinical trial. The study enrolled 1,063 patients with newly diagnosed AML (aged 0–29 years). Patients were randomly selected to receive five cycles of chemotherapy alone or in conjunction with 3 mg/m2 of gemtuzumab ozogamicin administered once a day on day 6 in Induction 1 and once a day on day 7 in Intensification 2.

In this trial, event-free survival was defined as patients being free of induction failure, relapse, or death by any cause. Event-free survival results were 48% in patients who received gemtuzumab ozogamicin and chemotherapy (95% confidence interval [CI] = 43%–52%) versus 40% in patients who had chemotherapy alone (95% CI = 36%–45%). The event-free survival hazard ratio was 0.84 (95% CI = 0.71–0.99). No difference in overall survival was found between the two groups.

The most common grade 3 or higher adverse reactions for gemtuzumab ozogamicin occurring in at least 5% of patients included infection, febrile neutropenia, decreased appetite, hyperglycemia, mucositis, hypoxia, hemorrhage, increased transaminase, diarrhea, nausea, and hypotension.

For detailed prescribing information on gemtuzumab ozogamicin, visit accessdata.fda.gov.


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