Mirvetuximab soravtansine
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-MIRVETUXIMAB-SORAVTANSINE |
|---|---|
| Тип | Препарат |
| Синоніми | ElahereIMGN853mirvmirvetuximab soravtansine-gynxМірветуксимаб соравтанзин |
| Статус | переглянуто 2026-04-27 | очікує клінічного підпису |
| Хвороби | DIS-OVARIAN |
| Джерела | SRC-ESMO-OVARIAN-2024 SRC-NCCN-OVARIAN-2025 |
Дані про препарат
| Клас | Folate receptor alpha (FRα)–directed antibody-drug conjugate (ADC) |
|---|---|
| Механізм дії | Humanized anti-FRα IgG1 monoclonal antibody (M9346A) conjugated via a cleavable disulfide-containing linker (sulfo-SPDB) to DM4 (ravtansine), a maytansinoid microtubule-disrupting cytotoxic payload (drug-to-antibody ratio ~3.5). After binding folate receptor alpha (FOLR1) expressed on epithelial ovarian / fallopian / primary peritoneal carcinomas, the ADC is internalized; lysosomal cleavage releases active DM4 catabolites that bind tubulin and cause mitotic arrest and apoptosis. Bystander effect from membrane-permeable catabolites partially compensates for heterogeneous FRα expression. Pivotal evidence MIRASOL (FRα-high platinum-resistant ovarian, 1-3 prior lines, vs investigator-choice chemotherapy): mPFS 5.6 vs 4.0 mo HR 0.65, ORR 42% vs 16%, mOS 16.5 vs 12.7 mo HR 0.67 — first PARPi-independent OS benefit in platinum-resistant ovarian. FDA full approval Mar 2024 (after accelerated 20... |
| Типове дозування | 6 mg/kg adjusted ideal body weight (AIBW) IV every 3 weeks until disease progression, unacceptable toxicity, or for at least 2 cycles to assess response. Use AIBW (not actual body weight) to reduce dose-related ocular toxicity. Pre-medication for ocular prophylaxis: corticosteroid eye drops (prednisolone acetate 1% 1 drop QID for 4 days starting 1 day before each infusion, then BID for 2 days) AND lubricating eye drops continuously. Standard IV pre-medication for infusion reactions: corticosteroid + antihistamine + acetaminophen for first 3 cycles. No formal renal or hepatic adjustment. |
| Зареєстровано в Україні | False |
| Відшкодовується НСЗУ | False |
| Остання перевірка для України | 2026-04-27 |
Застереження
- Ocular toxicity (boxed warning) — keratopathy / blurred vision / dry eye / photophobia / cataract / uveitis; severe events including corneal ulcer can occur; mandate baseline + every-other-cycle ophthalmologic exam (visual acuity + slit-lamp); withhold for G2-3 ocular toxicity until improvement to ≤G1, permanently discontinue G4 or persistent G3
Нотатки
Eligibility gate: FRα-high tumor by VENTANA FOLR1 (FOLR1-2.1) IHC ≥75% of tumor cells with ≥2+ membrane staining intensity (PS2+). Subcohorts with lower FRα expression have not shown benefit and are excluded from the indication. Mandatory baseline + every- other-cycle ophthalmologic examination (visual acuity, slit-lamp, fundoscopy if symptoms) — collaboration with ophthalmology is essential and access can be a real-world barrier. Counsel patients to use lubricating drops continuously and corticosteroid drops per protocol; report any new visual symptom immediately. Use AIBW dosing (not actual BW) to reduce ocular AE incidence. Standard IV pre-medication for first 3 cycles (corticosteroid + antihistamine + acetaminophen) reduces infusion reactions. UA access via EAP / cross-border / self-pay — no UA НСЗУ pathway.
Де використовується
Regimens
REG-MIRVETUXIMAB-OVARIAN- Mirvetuximab soravtansine (FRα-high platinum-resistant ovarian, MIRASOL)