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MYLOTARG® (gemtuzumab ozogamicin)
MYLOTARG is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients aged 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL)1.
MYLOTARG is NICE2 recommended and SMC3 accepted as an option in this indication for patients with favourable, intermediate or unknown cytogenics and can be initiated whilst awaiting cytogenic or molecular testing results.
MYLOTARG is indicated for first-line use in de novo CD33-positive AML, except APL1
MYLOTARG can be initiated from Day 1 whilst awaiting cytogenic or molecular testing results. When results are available, it should be assessed whether the benefit of continuing MYLOTARG outweighs the risk.1
MYLOTARG + standard front-line chemotherapy demonstrated improved EFS across a range of patient subgroups vs standard front-line chemotherapy.4 MYLOTARG did not demonstrate improved EFS in adverse risk cytogenics.4
Dosing schedule for MYLOTARG in combination with standard chemotherapy.1
Data from the Phase III ALFA-0701 trial evaluating MYLOTARG + standard front-line chemotherapy vs. standard front-line chemotherapy alone.4
AML patient case studies
A real-world AML case highlighting the use of Mylotarg in a patient with favourable-risk disease, achieving MRD-negative remission and avoiding transplant.
A real-world AML case exploring intensive treatment with Mylotarg in an older patient with intermediate-risk disease and the path to stem cell transplantation.
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Example
Example
Example
Example
Click here to view the MYLOTARG Digital brochure
Abbreviations:
AML, Acute Myeloid Leukaemia; CD33, cluster of differentiation 33; EFS, event-free survival; NICE, National Institute for Health and Care Excellence; SMC, Scottish Medicines Consortium
References:
1. MYLOTARG Summary of Product Characteristics for the United Kingdom click here.
2. National Institute for Health and Care Excellence. Technology appraisal guidance (TA545): Gemtuzumab ozogamicin for untreated acute myeloid leukaemia (Published: 14 November 2018). Available at: Overview | Gemtuzumab ozogamicin for untreated acute myeloid leukaemia | Guidance | NICE
3. Scottish Medicines Consortium. Gemtuzumab ozogamicin (MYLOTARG): SMC2089 (Published: 08 October 2018). Available at: https://www.scottishmedicines.org.uk/medicines-advice/gemtuzumab-ozogamicin-mylotarg-fullsub-smc2089/
4. Lambert J, et al. Haematologica 2019;104:113–119.
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PP-UNP-GBR-13971. December 2025