Inotuzumab ozogamicin
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-INOTUZUMAB-OZOGAMICIN |
|---|---|
| Type | Drug |
| Aliases | BesponsaІнотузумаб озогаміцин |
| Status | reviewed 2026-04-25 | pending_clinical_signoff |
| Diseases | DIS-B-ALL |
| Sources | SRC-NCCN-BCELL-2025 |
Drug Facts
| Class | Anti-CD22 humanized IgG4 monoclonal antibody-drug conjugate (calicheamicin payload) |
|---|---|
| Mechanism | Humanized anti-CD22 IgG4 monoclonal antibody conjugated to N-acetyl-γ-calicheamicin dimethyl hydrazide (DNA-binding cytotoxic payload). Binds CD22 on B-ALL blasts, internalizes, releases calicheamicin → DNA double-strand breaks → apoptosis. Approved 2L+ for R/R Ph- B-ALL on basis of INO-VATE phase-3. |
| Typical dosing | Cycle 1 induction: 0.8 mg/m² IV day 1, 0.5 mg/m² IV days 8 + 15 (total 1.8 mg/m²). Cycle 2-6 (consolidation post-CR): 0.5 mg/m² IV days 1, 8, 15 (total 1.5 mg/m²). Cycles every 21-28 days. Discontinue if no response after 2 cycles. Standard course bridge to alloHCT. |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-04-27 |
Warnings
- Hepatotoxicity / VOD/SOS — risk increased with subsequent alloHCT (boxed); incidence ~14% post-HCT
- Increased mortality post-HCT vs comparator chemotherapy in INO-VATE (HR 1.31)
Notes
Pivotal: INO-VATE (Kantarjian et al., NEJM 2016) phase-3 in R/R Ph- B-ALL — inotuzumab vs investigator-choice salvage chemo; CR/CRi 80.7% vs 29.4%; MRD-negativity 78.4% vs 28.1%; median OS 7.7 vs 6.7 mo (HR 0.77). FDA approval Aug 2017. CRITICAL: VOD risk amplified by subsequent alloHCT — limit to 2 cycles pre-HCT, avoid dual alkylator conditioning, monitor LFT carefully. Bridge-to-HCT intent dominates use — typical strategy is 2 cycles inotuzumab → CR/CRi → urgent alloHCT. Ukraine: NOT registered — access via named-patient import / EAP Pfizer / cross- border (EMA-approved 2017). VOD risk amplified by subsequent alloHCT (~14% post-HCT vs 5% without HCT) — defibrotide prophylaxis considered in high-risk transplants per EBMT/JACIE guidelines.
Used By
Regimens
REG-BLINA-INOTUZUMAB-CONSOLIDATION-BALL- Blinatumomab + inotuzumab sequential consolidation (R/R Ph-negative B-ALL, MRD-directed b...REG-INOTUZUMAB-B-ALL- Inotuzumab ozogamicin for R/R Ph- B-ALL 2L+ (bridge to alloHCT)REG-INOTUZUMAB-BALL-ADULT-RR- Inotuzumab ozogamicin monotherapy (adult R/R B-ALL, CD22+)