Magrolimab
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-MAGROLIMAB |
|---|---|
| Тип | Препарат |
| Синоніми | Магролімаб |
| Статус | переглянуто 2026-04-29 | очікує клінічного підпису |
| Хвороби | Не вказано |
| Джерела | SRC-NCCN-AML-2025 |
Дані про препарат
| Клас | Anti-CD47 humanized IgG4 monoclonal antibody (innate-immunity / macrophage-checkpoint inhibitor) |
|---|---|
| Механізм дії | Humanized IgG4 monoclonal antibody binding CD47, a "do-not-eat-me" signal expressed on tumor cells that engages SIRPα on macrophages to inhibit phagocytosis. Blockade of CD47-SIRPα releases macrophages to phagocytose tumor cells (innate-immunity macrophage-checkpoint inhibition). Synergizes with pro-phagocytic signals from azacitidine / chemo-induced calreticulin exposure. Investigated principally in AML / MDS (TP53-mutant focus) and DLBCL. |
| Типове дозування | HISTORICAL — for archival / comparator-trial reference only. In clinical trials magrolimab was given IV with a priming-dose strategy (1 mg/kg priming dose to prevent on-target hemolytic anemia, then escalation to 30 mg/kg weekly maintenance) typically combined with azacitidine 75 mg/m² SC/IV days 1-7 of 28-day cycles. NEVER approved; no labeled dose exists. |
| Зареєстровано в Україні | False |
| Відшкодовується НСЗУ | False |
| Остання перевірка для України | 2026-04-29 |
Нотатки
STATUS: DEVELOPMENT DISCONTINUED — Gilead Sciences (acquired magrolimab via Forty Seven Inc, $4.9B, 2020) announced on February 14, 2024 the complete discontinuation of magrolimab AML and MDS development programs. DLBCL and solid-tumor (CRC, ovarian, bladder) programs were wound down through mid-late 2024. The decision followed: (1) FDA partial clinical hold on ENHANCE-2 (Phase III 1L TP53-mutant AML, magro+aza vs venetoclax+aza) in Aug 2023 — apparent excess mortality. (2) ENHANCE-3 (Phase III 1L AML unfit for intensive chemo, magro+ven+aza vs placebo+ven+aza) crossed pre-specified futility boundary at IDMC review Jan 2024. (3) Independent Data Monitoring Committee recommendation to halt all magrolimab AML / MDS studies. Magrolimab was the most clinically advanced anti-CD47 antibody; its failure raises questions about CD47-SIRPα as a therapeutic axis in myeloid malignancies generally — but next-generation CD47 / SIRPα agents (lemzoparlimab, evorpacept, AO-176) and bispecifics remain in earlier-phase development. KB retains this entry to: (a) document the failed program for clinical decision support (recommendation: do NOT seek magrolimab access for any patient — none available; d...
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