Glofitamab
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-GLOFITAMAB |
|---|---|
| Тип | Препарат |
| Синоніми | ColumviГлофітамаб |
| Статус | переглянуто 2026-04-29 | очікує клінічного підпису |
| Хвороби | Не вказано |
| Джерела | SRC-ESMO-DLBCL-2024 SRC-NCCN-BCELL-2025 |
Дані про препарат
| Клас | CD20 × CD3 bispecific T-cell engager (humanized IgG1; 2:1 CD20-bivalent / CD3-monovalent format; IV; time-limited) |
|---|---|
| Механізм дії | Humanized IgG1 bispecific antibody with a unique 2:1 format — two CD20-binding Fabs and one CD3-binding Fab — increasing avidity for CD20 and reducing affinity-driven CRS. Redirects polyclonal T-cell cytotoxicity to CD20+ malignant B-cells. Obinutuzumab pretreatment 1000 mg IV day -7 (single dose, 7 days before first glofitamab dose) depletes circulating B-cells to mitigate first-dose CRS. Step-up dosing schedule further attenuates CRS. Time-limited regimen (12 cycles maximum) — contrast to indefinite continuous bispecifics. |
| Типове дозування | Obinutuzumab pretreatment: 1000 mg IV day -7 (single dose, 7 days before first glofitamab dose; depletes circulating B-cells — mandatory CRS mitigation). Step-up dosing (cycle 1, 21-day cycle): 2.5 mg IV day 8, 10 mg IV day 15. Cycle 2 onward: 30 mg IV day 1 of each 21-day cycle, total 12 cycles (or until progression / unacceptable toxicity, whichever earlier). FIXED-DURATION regimen — discontinue after 12 cycles even in responders. |
| Зареєстровано в Україні | False |
| Відшкодовується НСЗУ | False |
| Остання перевірка для України | 2026-04-29 |
Застереження
- Cytokine release syndrome (CRS) — ~63% any grade, ~4% Grade ≥3 in NP30179
- Neurologic toxicity / ICANS (~8%)
- Serious infections — Grade ≥3 ~16%
- Tumor flare / TLS in high-burden disease — obinutuzumab pretreatment + step-up mitigates
Нотатки
NP30179 (Dickinson 2022, NEJM): r/r DLBCL after ≥2 prior lines (median 3; ~33% post-CAR-T) — ORR 52%, CR 39%, mDOR ~18 mo in CR cohort. FDA accelerated approval Jun 2023; EMA Jul 2023. Distinguishing features vs other CD20×CD3 bispecifics: (1) FIXED-duration 12 cycles — finite total exposure; (2) 2:1 format with bivalent CD20 binding — higher avidity, potentially deeper responses; (3) Mandatory obinutuzumab pretreatment 7 days before C1D1; (4) IV administration only (vs SC epcoritamab). Trade-offs: requires hospital/infusion-center infrastructure; obinutuzumab adds ~7 days to time-to-treatment. Lower long-term infection burden vs continuous bispecifics owing to fixed duration. Useful sequencing post-CAR-T progression in DLBCL. NOTE: Pivotal trial Source SRC-NP30179-DICKINSON-2022 not yet in KB — evidence base cited via NCCN-BCELL and ESMO-DLBCL guideline references; flag for source-stub creation.
Де використовується
Regimens
REGIMEN-GLOFITAMAB-MONO-DLBCL-3L- Glofitamab IV monotherapy with obinutuzumab pretreatment, fixed-duration 12 cycles, for r...