gemtuzumab ozogamicin
Trade name: mylotarg
mAbapprovedADCOrphan Drug FDA
Approved
May 17, 2000
Gemtuzumab ozogamicin, sold under the brand name Mylotarg, is an antibody-drug conjugate that is used to treat acute myeloid leukemia (AML). — Wikipedia
Clinical trial activity
98 trials · 86 clinical orgs · 3 marketing orgs
Phase 1
26
Phase 2
71
Phase 3
22
Phase 4
3
Earliest trial started Feb 1, 1997 (NCT00003131)
Timeline
2000s
- May 17, 2000
American Home Products — Earliest FDA Approval
- May 17, 2000
American Home Products — NDA Secondary Org
- May 17, 2000
Wyeth — NDA Secondary Org
- May 17, 2000
American Home Products — NDA Organization
- Jan 1, 2001
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2002
2010s
- Sep 1, 2017
Pfizer — NDA Secondary Org
Indications
Studied for
- Bone Marrow Cells · Phase 2
- Electrocardiography · Phase 4
- Infusions, Intravenous · Phase 4
- Leukemia · Phase 3
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 1/Phase 2
- Leukemia, Monocytic, Acute · Phase 2
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 2
- Leukemia, Myeloid · Phase 1/Phase 2
- Leukemia, Myeloid, Acute · Phase 4
- Leukemia, Myeloid, Chronic-Phase · Phase 2
- Leukemia, Myelomonocytic, Acute · Phase 2
- Leukemia, Myelomonocytic, Chronic · Early Phase 1
- Leukemia, Myelomonocytic, Juvenile · Phase 1
- Leukemia, Promyelocytic, Acute · Phase 2
- Myelodysplastic Syndromes · Phase 3
- Myeloproliferative Disorders · Phase 2
- Pharmacokinetics · Phase 4
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Safety · Phase 4
- Sarcoma, Myeloid · Phase 2
- Transplantation, Homologous · Phase 1/Phase 2
Mechanism of action
- Myeloid cell surface antigen CD33BINDING AGENT
CD33 binding agent
targets ozogamicin to cell
- DNADISRUPTING AGENT
DNA disrupting agent
intercalates DNA and causes double strand breakage
- Myeloid cell surface antigen CD33INHIBITOR
CD33 inhibitor
- DNAINHIBITOR
DNA inhibitor
intercalates DNA and causes double strand breakage
Approval history
- approvedAcceleratedMay 17, 2000
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Multi-specific
- No
- Payload
- calicheamicin
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaGemtuzumab ozogamicin ↗
- NCATS8GZG754X6M ↗
- ChEMBLCHEMBL2108342 ↗
- ChEMBLCHEMBL1201506 ↗
Also known as
- cdp-771
- cdp-771
- cma 676
- cma-676
- cma-676
- cma-676
- cmc-676
- gemtuzumab
- gemtuzumab
- gemtuzumab
- gemtuzumab ozogamicin
- gemtuzumab ozogamicin
- gemtuzumab ozogamicin
- gemtuzumab ozogamicin
- gemtuzumab ozogamicin
- gemtuzumab ozogamicin
- gemtuzumab ozogamicin
- gemtuzumab ozogamicin
- gemtuzumab ozogamicin
- gemtuzumab ozogamicin
- gemtuzumab-ozogamicin
- gemtuzumab ozogamycin
- mylotarg
- mylotarg
- mylotarg
- mylotarg
- mylotarg
- way-cma-676
- way-cma-676
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06917911 | Phase 2 | Nov 20, 2025 | National Cancer Institute (NCI) |
| NCT06448013 | Phase 1 | Nov 29, 2024 | Kura Oncology, Inc., University of Texas at Houston |
| NCT05662904 | Phase 1 | Dec 31, 2023 | German Cancer Research Center, Technical University of Dresden, University of Heidelberg |
| NCT05716009 | Phase 1 | Dec 10, 2023 | Johns Hopkins University |
| NCT05904106 | Phase 2 | Aug 31, 2023 | AbbVie, Technical University of Dresden, University of Heidelberg |
| NCT05955261 | Phase 2 | Jul 25, 2023 | AbbVie, St. Jude Children's Hospital |
| NCT05199051 | Phase 2 | Jan 30, 2023 | University of Nice Sophia Antipolis, University of Paris |
| NCT05183035 | Phase 3 | Oct 1, 2022 | AbbVie, LLS PedAL Initiative, LLC, Princess Maxima Center for Pediatric Oncology, Roche, St. Jude Children's Hospital |
| NCT05558124 | Phase 1 | Sep 22, 2022 | Jazz Pharmaceuticals, University of South Florida |
| NCT05599360 | Phase 2 | Aug 7, 2022 | Hebrew University |
| NCT04849910 | Phase 1/Phase 2 (Phase 2) | Aug 31, 2021 | Vor Biopharma |
| NCT04915612 | Phase 1 | May 21, 2021 | University of Texas at Houston |
| NCT04293562 | Phase 3 | Apr 4, 2020 | National Cancer Institute (NCI) |
| NCT04093505 | Phase 3 | Mar 1, 2020 | University of Heidelberg |
| NCT04168502 | Phase 3 | Feb 1, 2020 | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| NCT04207190 | Phase 1/Phase 2 (Phase 2) | Feb 1, 2020 | Pfizer, State University of New York, Buffalo |
| NCT04326439 | Phase 2 | Jan 24, 2020 | Emory University |
| NCT04070768 | Phase 1 | Oct 31, 2019 | AbbVie, Big Ten Cancer Research Consortium, Pfizer, University of Illinois at Chicago |
| NCT04173585 | Phase 2 | Oct 22, 2019 | University of Heidelberg |
| NCT04793919 | Phase 2 | Oct 9, 2019 | Associazione Italiana Ematologia Oncologia Pediatrica, Bambino Gesù Hospital and Research Institute |
Showing 20 of 98 trials
Page 1 / 5
Organizations
Research & Development (86)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 24 | 8 | 4 | 2000 |
| Pfizer | For profit | 21 | 9 | 5 | 1997 |
| University of Texas at Houston | Academic/Hospital | 10 | 10 | 3 | 2001 |
| University of Washington | Academic/Hospital | 8 | 5 | 3 | 2000 |
| Wyeth | For profit | 7 | 0 | 3 | 1997 |
| AbbVie | For profit | 4 | 0 | 3 | 2019 |
| European Organisation for Research and Treatment of Cancer | Academic/Hospital | 4 | 4 | 2 | 2000 |
| Southwest Oncology Group | Academic/Hospital | 4 | 3 | 2 | 2003 |
| University of Heidelberg | Academic/Hospital | 4 | 2 | 3 | 2019 |
| University of Paris | Academic/Hospital | 4 | 2 | 2 | 2006 |
| Cardiff University | Academic/Hospital | 3 | 1 | 1 | 2005 |
| Gruppo Italiano Malattie EMatologiche dell'Adulto | Academic/Hospital | 3 | 1 | 1 | 2002 |
| Jazz Pharmaceuticals | For profit | 3 | 0 | 1 | 2019 |
| New York Medical College | Academic/Hospital | 3 | 3 | 2 | 2004 |
| St. Jude Children's Hospital | Academic/Hospital | 3 | 2 | 2 | 2002 |
| Technical University of Dresden | Academic/Hospital | 3 | 2 | 2 | 2004 |
| University of South Florida | Academic/Hospital | 3 | 1 | 3 | 2002 |
| Cancer Research UK | Academic/Hospital | 2 | 0 | 1 | 2014 |
| Columbia University | Academic/Hospital | 2 | 1 | 1 | 2004 |
| Cornell University | Academic/Hospital | 2 | 2 | 2 | 2003 |
86 organizations
Page 1 / 5
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| American Home Products | For profit | NDA2 | May 17, 2000 |
| American Home Products | For profit | NDA | May 17, 2000 |
| Pfizer | For profit | NDA2 | Sep 1, 2017 |
| Wyeth | For profit | NDA2 | May 17, 2000 |