Blinatumomab
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-BLINATUMOMAB |
|---|---|
| Type | Drug |
| Aliases | BlincytoБлінатумомаб |
| Status | reviewed 2026-04-25 | pending_clinical_signoff |
| Diseases | DIS-B-ALL |
| Sources | SRC-NCCN-BCELL-2025 |
Drug Facts
| Class | Bispecific T-cell engager (BiTE) — anti-CD19 × anti-CD3 |
|---|---|
| Mechanism | Bispecific single-chain antibody construct binding CD19 on B-cell malignancies AND CD3 on T cells, forming an immunological synapse that activates polyclonal cytotoxic T-cell killing of CD19+ blasts. First-in-class BiTE. Approved for MRD+ post-induction B-ALL (BLAST trial) AND R/R Ph- and Ph+ B-ALL. |
| Typical dosing | R/R B-ALL: cycle 1: 9 µg/day continuous IV infusion days 1-7, then 28 µg/day days 8-28 of 42-day cycle. Cycles 2-5: 28 µg/day days 1-28. Up to 9 cycles total. MRD+ B-ALL: 28 µg/day continuous IV days 1-28 of 42-day cycle, up to 4 cycles. Continuous IV via ambulatory infusion pump. Hospitalization recommended for cycle 1 days 1-9 + cycle 2 days 1-2. |
| Ukraine registered | True |
| NSZU reimbursed | True |
| Ukraine last verified | 2026-04-27 |
Warnings
- Cytokine release syndrome (CRS) — fatal if not managed; Grade ≥3 ~2-15%
- Neurotoxicity (encephalopathy, seizures, ataxia, aphasia) — Grade ≥3 ~10-15%
Notes
Pivotal trials: TOWER (R/R Ph- B-ALL phase-3 vs chemo: median OS 7.7 vs 4.0 mo, HR 0.71); BLAST (MRD+ B-ALL phase-2: MRD response 78%); ALCANTARA (R/R Ph+ post-TKI). FDA approval Dec 2014; EMA Nov 2015. MRD+ indication added 2018. Continuous infusion + hospitalization for cycle 1 limit accessibility (inpatient stay required for cycle 1 days 1-9 + cycle 2 days 1-2 to monitor for CRS / ICANS). Ukraine: registered + НСЗУ-reimbursed for B-ALL R/R (TOWER) and MRD+ post-induction (BLAST), including pediatric. Continuous IV infusion via ambulatory pump; line-care training mandatory for outpatient cycles.
Used By
Regimens
REG-BLINA-INOTUZUMAB-CONSOLIDATION-BALL- Blinatumomab + inotuzumab sequential consolidation (R/R Ph-negative B-ALL, MRD-directed b...REG-BLINATUMOMAB-B-ALL- Blinatumomab BiTE for MRD+ post-induction OR R/R B-ALLREG-BLINATUMOMAB-BALL-ADULT-RR- Blinatumomab monotherapy (adult R/R Ph-negative B-ALL)