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Information on how to access Mylotarg™​​​​​​​​​​​​​​ (gemtuzumab ozogamicin) and cytarabine prescribing information and adverse event reporting 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 age 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

View EFS data

Think MYLOTARG

First line
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MYLOTARG is indicated for use in de novo AML3

From Day 1
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MYLOTARG can be initiated 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*

*NICE and SMC advise use in patients with a favourable, intermediate or unknown cytogenetic profile1,2

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

Efficacy and Safety of MYLOTARG 

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

Learn more on Efficacy & Safety

AML Landscape

Watch Dr Eleni Tholouli discuss the NICE approval for MYLOTARG and efficacy data using the ALFA schedule

Learn more on Efficacy


AML, Acute Myeloid Leukaemia; EFS, event-free survival; NICE, National Institute for Health and Care Excellence
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.
References: 
  1. MYLOTARG Summary of Marketing Product Characteristics. (accessed March 2021)
  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: https://www.nice.org.uk/guidance/TA545/history. Accessed March 2021.
  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/  [accessed March 2021].Accessed March 2021.
  4. Lambert J, et al. Haematologica 2019;104:113–119.
PP-MYL-GBR-0224. March 2021

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PP-PFE-GBR-2688. December 2020

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