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Gemtuzumab ozogamicin

Alternative Names: gemtuzumab ozogamicin, mylotarg
Latest Update: 2024-04-05
Latest Update Note: Clinical Trial Update

Product Description

A drug used alone or with other drugs to treat acute myeloid leukemia that is CD33 positive (expresses the protein CD33). It is used in adults and in children aged 1 month and older whose disease is newly diagnosed. It is also used in adults and in children aged 2 years and older whose disease has come back or has not gotten better with other treatment. It is also being studied in the treatment of other types of cancer. Gemtuzumab ozogamicin contains a monoclonal antibody that binds to CD33, which is found on some leukemia cells. It also contains an anticancer drug, which may help kill cancer cells. Gemtuzumab ozogamicin is a type of antibody-drug conjugate. Also called Mylotarg. (Sourced from: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/gemtuzumab-ozogamicin)

Mechanisms of Action: CD33 Antagonist

Novel Mechanism: No

Modality: Antibody Drug Conjugate

Route of Administration: Intravenous

FDA Designation: None *

Approval Status: Approved

Approved Countries: Australia | Austria | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Netherlands | New Zealand | Norway | Poland | Portugal | Romania | Russia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Turkey | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela

Approved Indications: Acute Leukemia | Acute Myeloid Leukemia | Leukemia | Myeloid Leukemia

Known Adverse Events: Headache | Mucositis

Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Gemtuzumab ozogamicin

Countries in Clinic: Germany, United States

Active Clinical Trial Count: 3

Highest Development Phases

Phase 3: Acute Myeloid Leukemia



Trial Status


Primary Completion Date

Probability of Success



Not yet recruiting

Acute Myeloid Leukemia





Acute Myeloid Leukemia





Acute Myeloid Leukemia


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