# Inotuzumab ozogamicin

Source: https://onco.cc/drugs/inotuzumab-ozogamicin/  
OnCo record `inotuzumab-ozogamicin` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Inotuzumab ozogamicin is an antibody carrying a DNA-cutting toxin to CD22 on leukaemia cells. It gets far more relapsed ALL patients into remission than chemotherapy and bridges them to transplant.

## Summary

INO-VATE (n=326): CR/CRi 80.7% vs 29.4% vs standard chemotherapy, more MRD-negative remissions and transplants; OS 7.7 vs 6.7 months (HR 0.77), statistically significant on the 2-year landmark. Approved 2017 (adults); paediatric approval 2024 (ITCC-059). Hepatic veno-occlusive disease after transplant (boxed warning) is mitigated by limiting cycles and avoiding dual-alkylator conditioning. Moving frontline for older adults (ALLIANCE A041501; Mini-hyper-CVD + InO) and children (COG AALL1732).

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Besponsa
- Modality: ADC
- Mechanism: Humanised anti-CD22 IgG4 internalises; acid-cleaved calicheamicin binds the DNA minor groove and causes double-strand breaks.
- Payload: Calicheamicin (DNA-cleaving enediyne), DAR ~6
- Linker: Acid-labile hydrazone (AcBut)
- Approvals: US 2017: Relapsed/refractory CD22+ B-ALL, adults; US 2024: Paediatric patients ≥1 year with relapsed/refractory CD22+ B-ALL
- Dosing: IV over 1 hour; Cycle 1: 0.8 mg/m² day 1, 0.5 mg/m² days 8 and 15 (21-day cycle); subsequent cycles 0.5 mg/m² days 1, 8, 15; limit to 2 cycles if proceeding to transplant, maximum 6
- Toxicity (grade 3+): Thrombocytopenia 41%; Febrile neutropenia 27%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Inotuzumab_ozogamicin
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Inotuzumab%20ozogamicin

## Connected records

- biomarkers: [CD22 expression (CD22-positive)](https://onco.cc/biomarkers/cd22-expression/)
- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/), [High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL)](https://onco.cc/cancers/all-paediatric-high-risk/), [Philadelphia chromosome-positive acute lymphoblastic leukaemia in children (Ph-positive ALL)](https://onco.cc/cancers/all-paediatric-ph-positive/), [Relapsed and refractory acute lymphoblastic leukaemia in children](https://onco.cc/cancers/all-paediatric-relapsed/), [Standard-risk B-cell acute lymphoblastic leukaemia in children](https://onco.cc/cancers/all-paediatric-standard-risk/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/)
- targets: [CD22](https://onco.cc/targets/cd22/)
- companies: [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/)
- terms: [Linker (ADC)](https://onco.cc/terms/linker/), [Payload (ADC)](https://onco.cc/terms/payload/)
- trials: [A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL](https://onco.cc/trials/nct05748171/), [INO-VATE ALL](https://onco.cc/trials/ino-vate/), [Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia](https://onco.cc/trials/nct03150693/)
- pairings: [Caution: inotuzumab before transplant (veno-occlusive disease)](https://onco.cc/pairings/inotuzumab-then-transplant-caution/)
- key papers: [INO-VATE: inotuzumab ozogamicin, a CD22 antibody-drug conjugate, versus chemotherapy for relapsed adult B-cell ALL](https://onco.cc/key-papers/paper-ino-vate-inotuzumab-all-nejm-2016/)

---
JSON: https://onco.cc/api/v1/entities/inotuzumab-ozogamicin.json