Gemtuzumab ozogamicin
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-GEMTUZUMAB-OZOGAMICIN |
|---|---|
| Type | Drug |
| Aliases | MylotargГемтузумаб озогаміцин |
| Status | reviewed 2026-04-25 | pending_clinical_signoff |
| Diseases | DIS-AML DIS-APL |
| Sources | SRC-NCCN-AML-2025 |
Drug Facts
| Class | Anti-CD33 humanized IgG4 monoclonal antibody-drug conjugate (calicheamicin payload) |
|---|---|
| Mechanism | Humanized anti-CD33 IgG4 monoclonal antibody conjugated to N-acetyl-γ-calicheamicin dimethyl hydrazide. Binds CD33 on myeloid blasts (>80% AML express CD33; APL especially CD33+), internalizes, releases calicheamicin → DNA double-strand breaks → apoptosis. Originally withdrawn 2010 over OS concerns; reapproved 2017 at fractionated lower dose with improved safety profile. Used in newly-dx CD33+ AML (ALFA-0701) and salvage CD33+ AML + relapsed APL (MyloFrance). |
| Typical dosing | Newly-dx AML (ALFA-0701): 3 mg/m² IV (max 4.5 mg) days 1, 4, 7 of induction + day 1 of each consolidation. R/R AML / APL (MyloFrance): 3 mg/m² IV days 1, 4, 7. Single-agent salvage dose: 6 mg/m² IV day 1 + 3 mg/m² IV day 8. |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-04-27 |
Warnings
- Hepatotoxicity / VOD/SOS (boxed) — risk increased with subsequent alloHCT
- Severe + prolonged myelosuppression
Notes
Anti-CD33 ADC. ALFA-0701 (Castaigne et al., Lancet 2012) — newly dx AML 50-70 + 7+3 + GO at fractionated dose: improved EFS + RFS. MyloFrance-1 (Aribi et al., Cancer 2007) — single-agent GO in r/r APL post-ATRA-ATO: CR ~91% (relapsed APL exquisitely CD33+; rapid deep MRD-negative responses). VOD risk dominant safety concern — dose-fractionation (3 mg/m² × 3 doses spaced Days 1, 4, 7) reduced VOD incidence vs original 9 mg/m² single dose, allowing 2017 reapproval after 2010 withdrawal. Limit to 2 cycles pre-alloHCT; avoid dual-alkylator conditioning to minimize VOD risk. Ukraine: NOT registered — access via named- patient import / EAP Pfizer / cross-border (EMA-approved 2018).
Used By
Indications
IND-AML-PEDIATRIC-AAML1031- IND-AML-PEDIATRIC-AAML1031
Regimens
REG-AML-7-3-GO- 7+3 + fractionated gemtuzumab ozogamicin (CD33+ AML, 1L; ALFA-0701)REG-GEMTUZUMAB-APL- Gemtuzumab ozogamicin for relapsed APL with maintenance