Inotuzumab ozogamicin
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.
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), 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).
1.Antibody binds CD22 on the B-lymphoblast
- Route
- IV over 1 hour
- Schedule
- 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
- Monitoring
- Liver enzymes and bilirubin (VOD boxed warning), counts, QT
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies.
- Commercial insurance
- covered with prior authorisation
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
- Assistance programmes
- Pfizer Oncology Together
- Pfizer RxPathways
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Appraised for
- Relapsed or refractory CD22-positive B-cell precursor ALL
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA541 · SMC advice: inotuzumab ozogamicin. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 17 Aug 2017ApprovalUS
INO-VATE
- 6 Mar 2024Label changeUS
Paediatric expansion
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2017 | Relapsed/refractory CD22+ B-ALL, adults |
| US | 2024 | Paediatric patients ≥1 year with relapsed/refractory CD22+ B-ALL |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Hepatic veno-occlusive disease | 14% | — |
| Thrombocytopenia | — | 41% |
| Febrile neutropenia | — | 27% |
| Transaminase elevation | 27% | — |
Boxed warning; 22% of those who went on to transplant in INO-VATE. Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Inotuzumab ozogamicin" OR ABSTRACT:"Inotuzumab ozogamicin" OR TITLE:"Besponsa" OR ABSTRACT:"Besponsa") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Inotuzumab ozogamicin, not a curated reading list.
Pages like this
not linked directly; found by shared links- PersonHagop M. Kantarjian
Shares INO-VATE ALL, INO-VATE: inotuzumab ozogamicin, a CD22 antibody-drug conjugate, versus chemotherapy for relapsed adult B-cell ALL, Acute lymphoblastic leukaemia.
- ProductMoxetumomab pasudotox
Shares CD22, Antibody-drug conjugate (ADC).
- TermProdrug
Shares Linker (ADC), Payload (ADC), Antibody-drug conjugate (ADC).
- IdeaPlatform designation for ADC linker-payloads so manufacturing data carry across
Shares Linker (ADC), Payload (ADC), Antibody-drug conjugate (ADC).
- PersonNirali N. Shah
Shares CD22, Acute lymphoblastic leukaemia.
- TermSMCC (thioether, non-cleavable)
- TermSulfo-SPDB (disulfide)
- TermMaleimidocaproyl (mc), non-cleavable