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i3 Health News & Perspectives: Gemtuzumab Ozogamicin for Pediatric Acute Myeloid Leukemia


By Keira Smith

In this interview, Alan S. Gamis, MD, MPH, speaks with i3 Health about the recent FDA approval of gemtuzumab ozogamicin for pediatric patients aged 1 month and older with newly diagnosed CD33-positive acute myeloid leukemia (AML). Dr. Gamis, lead investigator of the phase 3 Children's Oncology Group Trial AAML0531, which provided the basis for the approval, discusses the significance of the approval and shares his advice for health care providers as they begin prescribing gemtuzumab ozogamicin for their patients.


How do you foresee the treatment of pediatric and young adult patients with newly diagnosed CD33-positive AML evolving in the coming years?

Dr. Gamis: The broad use of gemtuzumab ozogamicin will hopefully lead to greater relapse-free survival in these patients—this is the primary benefit seen in trials to date. With further research, we hope to more accurately predict who will benefit from this agent's use and who will not, thus being able to utilize it more wisely. The approval of gemtuzumab ozogamicin validates and strengthens an immunologic approach to AML therapy from which future therapies can build.


Do you have any words of advice for community oncologists and hematologists treating pediatric and young adult patients with gemtuzumab ozogamicin?

Dr. Gamis: While gemtuzumab ozogamicin is a step towards improved care, it needs to be used wisely. In AAML0531, we utilized it early in therapy, on the day after the last anthracycline treatment was given. Our data suggests that this is a safe and effective approach to its administration. We identified that later use of it, given as a second overall dose during intensification, was associated with toxicity. Thus, while it has not been studied or validated via a randomized trial, we would only give a single dose or set of doses—such as seen in the ALFA-0701 trial—during the first course of induction. We now consider it a standard of care. Further studies are underway to assess whether the degree of CD33 expression on the leukemic cell truly correlates with efficacy. The impact of CD33 polymorphism on efficacy is also being researched. Watch for these results, which will hopefully allow for wiser utilization of this new agent in the future.


Read the full article via i3 Health News & Perspectives

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