Blinatumomab
Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.
| ID | DRUG-BLINATUMOMAB |
|---|---|
| Type | Médicament |
| Alias | BlincytoБлінатумомаб |
| État | reviewed 2026-04-25 | pending_clinical_signoff |
| Maladies | DIS-B-ALL |
| Sources | SRC-NCCN-BCELL-2025 |
Faits sur les drogues
| Catégorie | Enregistreur bispécifique pour cellules T (BiTE) — anti-CD19 × anti-CD3 |
|---|---|
| Mécanisme | 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. |
| Dose typique | 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 enregistrée | Vrai |
| NSZU remboursé | Vrai |
| Ukraine vérifiée pour la dernière fois | 2026-04-27 |
Avertissements
- Cytokine release syndrome (CRS) — fatal if not managed; Grade ≥3 ~2-15%
- Neurotoxicité (encéphalopathie, convulsions, ataxie, aphasie) — 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.
Utilisé par
Protocole thérapeutique
REG-BLINA-INOTUZUMAB-CONSOLIDATION-BALL- Blinatumomab + consolidation séquentielle de l'inotuzumab (R/R Ph-négatif B-ALL, MRD...REG-BLINATUMOMAB-B-ALL- Blinatumomab BiTE pour MRD+ post-induction OU R/R B-ALLREG-BLINATUMOMAB-BALL-ADULT-RR- Blinatumomab en monothérapie (Adulte R/R Ph-Négatif B-ALL)