Home | MYLOTARG®▼(gemtuzumab ozogamicin)

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The content of this website has been produced in line with the MYLOTARG®▼ (gemtuzumab ozogamicin) Summary of Product Characteristics for Great Britain and Northern Ireland. For MYLOTARG®▼ (gemtuzumab ozogamicin) and cytarabine Prescribing Information Click here. Adverse event reporting information can be found at the bottom of the page.

MYLOTARG®▼(gemtuzumab ozogamicin)

Licensed indication:

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

NICE² and SMC³ have approved MYLOTARG as an option in this indication for patients with favourable, intermediate or unknown cytogenetics and can be initiated whilst awaiting cytogenetic or molecular testing results

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First-line MYLOTARG is indicated for first-line use in de novo CD33-postive AML, except APL¹	From Day 1 MYLOTARG can be initiated from Day 1 whilst awaiting cytogenetic or molecular testing results⁴	Across patient subgroups MYLOTARG demonstrates improved EFS across a range of patient subgroups (including mutation and risk status) vs standard of care.⁴ MYLOTARG did not demonstrate improved EFS in adverse risk cytogenetics.⁴

Dosing and Administration

Click below for dosing, schedule and administration information including Pharmacy and Dosing Guides available to download

View Dosing and Administration Information

Efficacy

Click here to view event-free survival (EFS) data by cytogenetic profile

View EFS data

Treating Patients with de novo AML in the DGH Setting

Watch Dr. Sreetharan Munisamy discuss the current treatment landscape for de novo AML in Video 1 of the Key Topics in the Management of de novo AML video series.
Click the link below to explore the rest of the on-demand series.

Dr Munisamy Video Series

Efficacy and safety of MYLOTARG

Watch Professor Robert Hills discuss the key clinical data from the pivotal ALFA-0701 study.

Learn more Efficacy and Safety

AML, Acute Myeloid Leukaemia; DGH, District General Hospital; EFS, event-free survival; NICE, National Institute for Health and Care Excellence; SMC, Scottish Medicines Consortium

References:

MYLOTARG Summary of Product Characteristics for Great Britain click here. MYLOTARG Summary of Product Characteristics for Northern Ireland click here.

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 [accessed April 2023]

Scottish Medicines Consortium. Gemtuzumab ozogamicin (MYLOTARG): SMC2089 (Published: 08 December 2021). Available at: https://www.scottishmedicines.org.uk/medicines-advice/gemtuzumab-ozogamicin-mylotarg-fullsub-smc2089/ [accessed April 2023]

Lambert J, et al. Haematologica 2019;104:113–119.

PP-MYL-GBR-0679. April 2023

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