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GEMTUZUMAB OZOGAMICIN
At a glance
| Generic name | GEMTUZUMAB OZOGAMICIN |
|---|---|
| Drug class | CD33-directed Immunoconjugate [EPC] |
| Modality | Antibody drug conjugate |
| Phase | FDA-approved |
| First approval | 2000 |
Approved indications
- Newly-diagnosed CD33-positive AML
- Relapsed or refractory CD33-positive AML
Boxed warnings
- WARNING: HEPATOTOXICITY Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG as a single agent, and as part of a combination chemotherapy regimen. Monitor frequently for signs and symptoms of VOD after treatment with MYLOTARG. ( 5.1 and 6.1 ) WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG. ( 5.1 , 6.1 )
Common side effects
- Infection
- Hemorrhage
- Veno-occlusive liver disease
Key clinical trials
- Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia (PHASE2)
- Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MyeloMATCH Treatment Trial) (PHASE2)
- MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (PHASE2)
- IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia. (PHASE3)
- Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia (PHASE2)
- A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and Relapsed /Refractory Pediatric Acute Leukemia Patients (PHASE1)
- CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML (PHASE1)
- A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- GEMTUZUMAB OZOGAMICIN CI brief — competitive landscape report
- GEMTUZUMAB OZOGAMICIN updates RSS · CI watch RSS