Mylotarg
Mylotarg ingredients
| Active ingredient | Strength |
|---|---|
| Gemtuzumab Ozogamicin | 5 mg/5mL |
What Mylotarg is used for
The FDA lists the approved uses on the official label (below). In the EU, gemtuzumab ozogamicin is approved as Mylotarg 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).
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Mylotarg
- Generic name
- Gemtuzumab ozogamicin
- Made by
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- Forms
- Injection, Powder, Lyophilized, For Solution
- Given
- Intravenous
- Drug class
- CD33-directed Immunoconjugate
- FDA approval
- Biologic licence (BLA) BLA761060
- On the US market since
- 2017
Official information
- Mylotarg prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Gemtuzumab ozogamicin)
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?
Mylotarg (Gemtuzumab ozogamicin) is a cancer medicine made by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., approved by the US FDA.
What are the ingredients of Mylotarg?
Mylotarg contains Gemtuzumab Ozogamicin (5 mg/5mL).
Is Mylotarg approved in Europe?
The same active substance is approved in the EU as Mylotarg.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
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