Mylotarg
What Mylotarg is used for
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).
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
Key facts
- Brand
- Mylotarg
- Active substance
- gemtuzumab ozogamicin
- Disease area
- Leukemia, Myeloid, Acute
- Medicine group
- Antineoplastic agents
- Marketing authorisation holder
- Pfizer Europe MA EEIG
- Authorised in the EU since
- 2018
Official information
In the USA
Same active substance: Mylotarg
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Mylotarg used for?
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).
What is the active substance in Mylotarg?
Mylotarg contains gemtuzumab ozogamicin.
Who makes Mylotarg?
The EU marketing authorisation holder is Pfizer Europe MA EEIG.
Is Mylotarg an orphan medicine?
Yes. Mylotarg is designated an orphan medicine in the EU, for a rare disease (Leukemia, Myeloid, Acute).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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