This site contains promotional information intended only for healthcare professionals resident in the United Kingdom
Menu
Close
Example of description text sitting alongside header
Example of description text sitting alongside header
Menu
Close
Example of description text sitting alongside header
Example of description text sitting alongside header
Menu
Close
Menu
Close
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.
The pivotal study for MYLOTARG is the randomised Phase III ALFA-0701 study. In this study, treatment-naive patients (n=280*, ITT population), aged 50-70 years, with confirmed AML and normal cardiac function✝ were randomised to receive either MYLOTARG 3mg/m2 (maximum one 5mg vial) days 1, 4 and 7 plus DNR/AraC 3+7 (n=139*) OR DNR/AraC (SoC) 3+7 (n=138*).1-4
The primary endpoint was event free survival (EFS), defined as the time from randomisation to relapse, death from any cause or time to the date of assessment of response if CR or CRp had not been achieved.2
*A total of 277 patients received treatment (n = 139, DNR/AraC + MYLOTARG arm; n = 138 DNR/AraC arm). Full details regarding patient flow are reported in Lambert et al.3-4
†Eligible patients required a locally confirmed morphological diagnosis of AML and normal cardiac function, assessed by use of radionucleotide scintigraphy or echography. CD33+ leukaemic blast cells were not required for study entry.
‡Original study allowed consolidation for patients with a complete remission with incomplete platelet recovery (CRp) but dosing modifications preclude the use of MYLOTARG for consolidation in patients with a platelet count of < 100,000/mm3.
§Without MYLOTARG and in patients who did not achieve CR/CRp after Course 1.
A retrospective analysis of the 235 patients with non-CBF AML from the ALFA-0701 study assessed the efficacy of MYLOTARG plus SoC according to ELN 2017 risk classification.6-7 Results showed that the addition of MYLOTARG to SoC significantly prolonged EFS vs. SoC alone in patients who had favourable- and intermediate-risk cytogenetics, with no benefit shown in those with adverse cytogenetics.5
Adapted from Fournier E, et al. Blood. 2020.6
*Primary endpoint: Investigator assessed event-free survival (EFS)
Adapted from Fournier E, et al. Blood. 2020.6
*Primary endpoint: Investigator assessed event-free survival (EFS)
Adapted from Fournier E, et al. Blood. 2020.6
*Primary endpoint: Investigator assessed event-free survival (EFS)
Watch Professor Robert Hills discuss the key clinical data from the pivotal ALFA-0701 study.
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.
AML, acute myeloid leukaemia; AraC, cytarabine; CBF, Core binding factor; CHEMO, chemotherapy; CI, confidence interval; CR, complete remission; CRp, complete remission with incomplete platelet recovery; DGH, District General Hospital; DNR, daunorubicin; EFS, event-free survival; ELN, European LeukemiaNet; HR, hazard rarios; ITT, intention-to-treat; mo, months; MYLO, MYLOTARG; SoC, standard chemotherapy
References
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.
This site is intended only for healthcare professionals resident in the United Kingdom. If you are a member of the public wishing to access information on a specific medicine, please visit www.medicines.org.uk/emc
This website is brought to you by Pfizer Limited, a company registered in England
and Wales under No. 526209 with its registered office at Ramsgate Road, Sandwich, Kent, CT13 9NJ
Copyright © 2023 Pfizer Limited. All rights reserved.
VAT registration number GB201048427
These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.
I confirm that I am a healthcare professional* resident in the United Kingdom.
If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.
*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.
PP-PFE-GBR-3863. November 2021