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), with daunorubicin (DNR) and cytarabine (AraC), is recommended as an option for untreated de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL), in people 15 years and over, only if:
Following a full submission assessed under the end of life and orphan medicine process2:
Gemtuzumab ozogamicin (Mylotarg) is accepted for restricted use within NHS Scotland.
Indication under review: For combination therapy with daunorubicin and cytarabine 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).
SMC restriction: use in patients with a favourable, intermediate or unknown cytogenetic profile.
In an open label, phase III study of adults with AML, the addition of gemtuzumab ozogamicin to standard intensive chemotherapy was associated with significant improvement in event free survival compared with standard intensive chemotherapy alone. Events included failure to achieve remission with induction therapy, relapse of disease, or death.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Watch Professor Robert Hills discuss the key clinical data from the pivotal ALFA study
Watch Dr Eleni Tholouli discuss the NICE approval for MYLOTARG and efficacy data using the ALFA schedule
Stay up to date with the latest relevant healthcare, medical and promotional information about medicines and vaccines promoted by Pfizer.
PP-PFE-GBR-2809. March 2021
Sign up now
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-2688. December 2020