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: *
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: None
Known Adverse Events: None
Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, France, Germany, Ireland, New Zealand, Switzerland, United Kingdom, United States
Active Clinical Trial Count: 9
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Acute Myeloid Leukemia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| MCC-21450 | P1 |
Recruiting |
Acute Myeloid Leukemia |
2025-11-01 |
23% |
2024-11-27 |
Primary Endpoints|Treatments |
| Myechild01 | P3 |
Recruiting |
Acute Myeloid Leukemia |
2031-12-01 |
47% |
2024-11-27 |
Primary Endpoints |
| NCI-2024-04821 | P1 |
Recruiting |
Acute Myeloid Leukemia |
2028-12-31 |
23% |
2025-03-13 |
Primary Endpoints |
| MOSAIC | P2 |
Recruiting |
Acute Myeloid Leukemia |
2027-04-01 |
80% |
2024-11-27 |
Primary Endpoints|Treatments |
| GO for MRD | P2 |
Recruiting |
Acute Myeloid Leukemia |
2025-12-31 |
12% |
2025-01-15 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| I 435819 | P1 |
Completed |
Acute Myeloid Leukemia |
2024-05-26 |
38% |
2024-11-02 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| BTCRC-AML17-113 | P1 |
Completed |
Acute Myeloid Leukemia |
2023-10-12 |
35% |
2025-05-06 |
Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| BrUOG 345 | P2 |
Active, not recruiting |
Acute Myeloid Leukemia |
2023-09-26 |
16% |
2024-02-09 |
Primary Completion Date|Primary Endpoints|Treatments |
| HCC 18-111 | P2 |
Completed |
Acute Myeloid Leukemia |
2023-02-02 |
38% |
2025-02-21 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
04/30/2025 |
News Article |
PureTech Announces Annual Results for Year Ended December 31, 2024 |
|
02/13/2025 |
News Article |
Vor Bio Presents Novel Research Highlighting Opportunities and Challenges Facing Institutions Enrolling Patients in Cell and Gene Therapy Trials |
|
12/27/2024 |
News Article |
Vor Bio Announces $55.6 Million Private Placement |
|
12/09/2024 |
News Article |
Vor Bio Provides Clinical Update Further Validating Approach of Using Shielded Transplants to Deliver Targeted Therapies; Receives Supportive Feedback from FDA Regarding Registrational Trial Design |