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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), 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).
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
Humanised anti-CD22 IgG4 internalises; acid-cleaved calicheamicin binds the DNA minor groove and causes double-strand breaks. Connects to CD22.
1.Antibody binds CD22 on the B-lymphoblast
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
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.
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.
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.
Sources: NICE TA541 · SMC advice: inotuzumab ozogamicin. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
INO-VATE
Paediatric expansion
| 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.
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Query 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.
Shares INO-VATE ALL, INO-VATE: inotuzumab ozogamicin, a CD22 antibody-drug conjugate, versus chemotherapy for relapsed adult B-cell ALL, Acute lymphoblastic leukaemia, Antibody-drug conjugate (ADC).
Shares INO-VATE ALL, INO-VATE: inotuzumab ozogamicin, a CD22 antibody-drug conjugate, versus chemotherapy for relapsed adult B-cell ALL, Acute lymphoblastic leukaemia.
Shares Standard-risk B-cell acute lymphoblastic leukaemia in children, Philadelphia chromosome-positive acute lymphoblastic leukaemia in children (Ph-positive ALL), High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL), Relapsed and refractory acute lymphoblastic leukaemia in children.
Shares Linker (ADC), Payload (ADC), Antibody-drug conjugate (ADC).
Shares Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia, Standard-risk B-cell acute lymphoblastic leukaemia in children, High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL).
Shares Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia, Standard-risk B-cell acute lymphoblastic leukaemia in children, High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL), Acute lymphoblastic leukaemia.
Shares Linker (ADC), Payload (ADC), Antibody-drug conjugate (ADC).
Shares Standard-risk B-cell acute lymphoblastic leukaemia in children, High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL), Acute lymphoblastic leukaemia.