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Besponsa (Inotuzumab Ozogamicin)
CD22-directed antibody-drug conjugate delivering cytotoxic calicheamicin to induce DNA breaks and apoptosis.
BESPONSA (inotuzumab ozogamicin) is a CD22-directed antibody-drug conjugate approved for relapsed or refractory CD22-positive B-cell precursor ALL in patients 1 year and older. The drug demonstrates strong mechanism with internalization-dependent delivery of cytotoxic calicheamicin payload inducing DNA breaks and apoptosis. Primary risk involves QT interval prolongation with concomitant QT-prolonging drugs requiring ECG monitoring and electrolyte assessment. The drug achieves steady-state by Cycle 4 with 5.3-fold accumulation and shows linear pharmacokinetics with 12.3-day half-life.
At a glance
| Generic name | Inotuzumab Ozogamicin |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Antibody-drug conjugate (ADC) |
| Target | CD22 |
| Modality | ADC |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| Annual revenue | 200 |
Mechanism of action
Inotuzumab ozogamicin is a CD22-directed antibody drug conjugate where a monoclonal antibody recognizing human CD22 is covalently attached via a linker to N-acetyl-gamma-calicheamicin, a small molecule cytotoxic agent. The ADC binds to CD22-expressing tumor cells, undergoes internalization of the ADC-CD22 complex, and releases N-acetyl-gamma-calicheamicin dimethylhydrazide intracellularly through hydrolytic cleavage of the linker. The released cytotoxic payload activates to induce double-strand DNA breaks, leading to cell cycle arrest and apoptotic cell death in CD22-positive B-cell precursor acute lymphoblastic leukemia cells.
Approved indications
- Relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult patients
- Relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in pediatric patients 1 year and older
Boxed warnings
- WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST-HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST- HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY See full prescribing information for complete boxed warning. • Hepatotoxicity
Common side effects
- Platelet count decreased
- Neutrophil count decreased
- Anaemia
- Pyrexia
- Nausea
- White blood cell count decreased
- Hypokalaemia
- Lymphocyte count decreased
- Neutropenia
- Aspartate aminotransferase increased
- Febrile neutropenia
- Diarrhoea
Drug interactions
- Drugs that prolong QT interval or induce Torsades de Pointes
Key clinical trials
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
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 |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Besponsa CI brief — competitive landscape report
- Besponsa updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI