Gemtuzumab ozogamicin
As of the edition of 20 October 2026, Gemtuzumab ozogamicin is an antibody drug conjugate: marketed, first approved in 2000 (US); acts on CD33; US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Antibody drug conjugate
- Brand name
- Mylotarg
- First approved
- 17 May 2000 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Pfizer; 3 holders in all
- Withdrawn from market
- 1 January 2010 (in some regions)
- Registered trials
- 93, 12 stopped early
- Disease areas
- Blood and lymph; Cancer; Inherited and neonatal; Immune system
US protection
US protection ends in 2029.
US protection ends in 2029, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Pfizer. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| CD33 | Myeloid cell surface antigen CD33 | P20138 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 2 | 0 | 0 |
| Phase 1 | 16 | 8 | 2 | 6 |
| Phase 2 | 53 | 35 | 12 | 4 |
| Phase 3 | 17 | 10 | 4 | 2 |
| Phase 4 | 2 | 2 | 0 | 0 |
| All trials | 93 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Lead sponsor of trials | 2000 to now |