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Inotuzumab ozogamicin-dose level 1
Inotuzumab ozogamicin is an anti-CD22 monoclonal antibody conjugated to a cytotoxic calicheamicin payload that binds to CD22 on B-cell lymphomas and delivers cell-killing chemotherapy directly to tumor cells.
Inotuzumab ozogamicin is an anti-CD22 monoclonal antibody conjugated to a cytotoxic calicheamicin payload that binds to CD22 on B-cell lymphomas and delivers cell-killing chemotherapy directly to tumor cells. Used for Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), Relapsed or refractory B-cell non-Hodgkin lymphoma.
At a glance
| Generic name | Inotuzumab ozogamicin-dose level 1 |
|---|---|
| Also known as | Besponsa |
| Sponsor | Pfizer |
| Drug class | Antibody-drug conjugate (ADC) |
| Target | CD22 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
The drug targets CD22, a surface antigen expressed on B-lineage hematologic malignancies. Upon binding, the antibody-drug conjugate is internalized and releases calicheamicin, a potent DNA-damaging agent, inside the tumor cell. This targeted delivery mechanism concentrates cytotoxicity on malignant B cells while sparing normal tissues.
Approved indications
- Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
- Relapsed or refractory B-cell non-Hodgkin lymphoma
Common side effects
- Thrombocytopenia
- Neutropenia
- Anemia
- Infection
- Nausea
- Vomiting
- Hepatotoxicity
- Sinusoidal obstruction syndrome (SOS)
Key clinical trials
- Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia (NA)
- A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia (PHASE3)
- Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy (PHASE2)
- A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL (PHASE2)
- Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy (PHASE2)
- Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL (PHASE1)
- Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab (PHASE1, PHASE2)
- Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia (PHASE2)
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 |
|---|---|
| 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:
- Inotuzumab ozogamicin-dose level 1 CI brief — competitive landscape report
- Inotuzumab ozogamicin-dose level 1 updates RSS · CI watch RSS
- Pfizer portfolio CI