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
Countries in Clinic: Australia, France, Germany, Ireland, New Zealand, Switzerland, United Kingdom, United States
Active Clinical Trial Count: 15
Highest Development Phases
Phase 3: Acute Myeloid Leukemia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| Venetoclax in children with relapsed AML | P3 |
Active, not recruiting |
Acute Myeloid Leukemia |
2032-02-17 |
|
| Myechild01 | P3 |
Recruiting |
Acute Myeloid Leukemia |
2031-12-01 |
|
| AIEOP-BFM AML 2020 | P3 |
Not yet recruiting |
Acute Myeloid Leukemia |
2029-12-31 |
|
| NCI-2024-04821 | P1 |
Not yet recruiting |
Acute Myeloid Leukemia |
2028-12-31 |