Mirvetuximab soravtansine
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| ID | DRUG-MIRVETUXIMAB-SORAVTANSINE |
|---|---|
| Tipo | Fármaco |
| Alegais | ElahereIMGN853mirvMirvetuximab soravtansine-gynxМірветуксимаб соравтанзин |
| Estado | reviewed 2026-04-27 | pending_clinical_signoff |
| Doenças | DIS-OVARIAN |
| Fontes | SRC-ESMO-OVARIAN-2024 SRC-NCCN-OVARIAN-2025 |
Fatos sobre as drogas
| Classe | Conjugado de anticorpos-médico direcionados para o receptor de folato alfa (FRα) (ADC) |
|---|---|
| Mecanismo | 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... |
| Dose típica | 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. |
| Ucrânia registada | Falso |
| NSZU reembolsado | Falso |
| Ucrânia verificada pela última vez | 2026-04-27 |
Avisos
- Toxicidade ocular (alarme em caixa) — queratopatia/ visão borrada/olho seco/fofobia/catarata/uveíte; podem ocorrer acontecimentos graves incluindo úlcera corneal; requerer a aplicação de um teste oftalmológico de base + todos os outros ciclos (acuidade visual + luz de fenda); adiar a toxicidade oculares G2-3 até melhorar para ≤G1, interromper permanentemente o G4 ou o G3 persistente
Notas
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.
Usado por
Esquema terapêutico
REG-MIRVETUXIMAB-OVARIAN- Mirvetuximab soravtansine (FRα-alto ovário resistente à platina, MIRASOL)