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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.

Key Highlights

Reinforce your 7 + 3 AML treatment with NICE and SMC approved MYLOTARG dosing1,2

Compared with intensive chemotherapy alone, fractionated dosing of MYLOTARG plus intensive chemotherapy in de novo AML offers:

MYLOTARG significantly extended the median EFS* vs DA chemotherapy alone from 9.5 months to 17.3 months (HR: 0.56; (95% CI: 0.42-0.76 P=0.0002)
MYLOTARG more than doubled 3 year EFS probability vs chemotherapy alone (13.6%  vs 39.8%)3,4​​​​​​​

​​​​​​​MYLOTARG more than doubled median RFS vs DA chemotherapy alone from 11.4 to 28 months (HR 0.526 ; 95% CI: 0.362–0.764) p=0.0006) 3,4​​​​​​​

With MYLOTARG, reinforce AML therapy by prolonging remission in more patients than with intensive chemotherapy alone*3,4

*Event Free Survival (EFS) was the primary endpoint for the study. Defined as the time from randomisation to the date of assessment of response (if CR or CRp had not been achieved), relapse or death. 

Median EFS was 17.3 months (95% CI: 13.4, 30.0) in the MYLOTARG arm versus 9.5 months (95% CI: 8.1, 12.0) in the DA alone arm; hazard ratio (HR) 0.562 (95% CI: 0.415, 0.762); 2-sided p=0.0002 by log-rank test.

Median RFS was 28.0 months (95% CI: 16.3, NE) in the MYLOTARG arm versus 11.4 months (95% CI; 10.0, 14.4) in the DA alone arm; hazard ration (HR) 0.526 (95% CI: 0.362, 0.764)

Explore more

Efficacy and Safety of MYLOTARG video

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

Learn more

AML Landscape: Present and Future video

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

Learn more


CI, Confidence Intervals; CR, Complete Remission, CRp, Complete Remission with incomplete platelet recovery;
DA, daunorubicin and cytarabine; EFS: Event-free Survival, HR, Hazard Ratio; mEFS, median Event-free Survival; NE, not estimable; RFS: Relapse-free survival

▼ 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. National Institute for Health and Care Excellence. Technolgy appraisal guidance (TA545): Gemtuzumab ozogamicin for untreated acute myeloid leukaemia (Published 14 November 2018). Available at: https://www.nice.org.uk/guidance/ta545/chapter/1-Recommendations [accessed March 2021].
  2. Scottish Medicines Consortium. Gemtuzumab ozogamicin (MYLOTARG): SMC2089 (Published: 08 October 2018). Available at: https://www.scottishmedicines.org.uk/medicines-advice/gemtuzumab-ozogami... [accessed March 2021].
  3. MYLOTARG Summary of Marketing Product Characteristics.
  4. Lambert J, et al. Haematologica 2019;104:113–119.
PP-MYL-GBR-0226. March 2021

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