TRANSLATE

The aml Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the aml Hub cannot guarantee the accuracy of translated content. The aml and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

The AML Hub is an independent medical education platform, sponsored by Astellas, Daiichi Sankyo, Johnson & Johnson, Kura Oncology and Syndax, and has been supported through educational grants from Bristol Myers Squibb and the Hippocrate Conference Institute, an association of the Servier Group. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.

Now you can support HCPs in making informed decisions for their patients

Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.

Find out more

FDA extends approval for gemtuzumab ozogamicin in newly diagnosed CD33-positive AML

By Sumayya Khan

Share:

Jun 19, 2020


On June 16, 2020, the U.S. Food and Drug Administration (FDA) extended the indication of gemtuzumab ozogamicin (GO) for newly diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients ≥ 1 month of age. This approval was based on data from the AAML0531 trial (NCT00372593).1

Study design1,2

  • Phase III, multicenter, randomized study of 1,063 patients with newly diagnosed AML who were between the ages of 0 and 29 years
  • Aimed to compare the efficacy of GO in combination with chemotherapy with that of chemotherapy alone
  • Patients were randomized to 5-cycle chemotherapy alone or with GO administered at 3 mg/m2 once on Day 6 in the induction 1 stage and once on Day 7 of the intensification 2 stage
  • Primary endpoint: Event-free survival (EFS), measured from the date of trial entry until induction failure, relapse, or death by any cause
  • The study started in August 2006 and completed in August 2013

Results1

  • EFS hazard ratio was 0.84 (95% CI, 0.71–0.99)
  • Estimated percentage of patients free of induction failure, relapse, or death at 5 years was 48% (95% CI, 43–52) in the chemotherapy plus GO arm vs 40% (95% CI, 36–45) in the chemotherapy alone arm
  • No demonstrable difference in overall survival between treatment arms
  • The most common ≥ Grade 3 adverse reactions occurring in at least 5% of patients treated with GO included infection, febrile neutropenia, decreased appetite, hyperglycemia, mucositis, hypoxia, hemorrhage, increased transaminase, diarrhea, nausea, and hypotension

GO was previously approved by the FDA for the treatment of adult patients with newly diagnosed CD33-positive AML. Ongoing trials AML18 and AML19 are investigating how GO should be applied in AML and whether a fractionated dosing schedule can provide benefit over a single dose.

References

Please indicate your level of agreement with the following statements:

The content was clear and easy to understand

The content addressed the learning objectives

The content was relevant to my practice

I will change my clinical practice as a result of this content