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
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