Mirvetuximab soravtansine
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-MIRVETUXIMAB-SORAVTANSINE |
|---|---|
| Type | Médicament |
| Alias | Elle-mêmeIMGN853lentillemirvetuximab soravtansine-gynxМірветуксимаб соравтанзин |
| État | reviewed 2026-04-27 | pending_clinical_signoff |
| Maladies | DIS-OVARIAN |
| Sources | SRC-ESMO-OVARIAN-2024 SRC-NCCN-OVARIAN-2025 |
Faits sur les drogues
| Catégorie | Conjugué d'anticorps dirigés contre le folate (FRα) (ADC) |
|---|---|
| Mécanisme | 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 typique | 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. |
| Ukraine enregistrée | Faux |
| NSZU remboursé | Faux |
| Ukraine vérifiée pour la dernière fois | 2026-04-27 |
Avertissements
- Toxicité oculaire (avertissement en boîte) — kératopathie/ vision floue/œil sec/phobie/cataracte/uvéite; des événements graves, y compris l'ulcère cornéen, peuvent survenir; mandater l'examen ophtalmologique de base + tous les autres cycles (acuité visuelle + lampe à fente); retenir la toxicité oculaire du G2-3 jusqu'à amélioration ≤G1, interrompre définitivement le G4 ou le G3 persistant
Notes
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.
Utilisé par
Protocole thérapeutique
REG-MIRVETUXIMAB-OVARIAN- Mirvetuximab soravtansine (ovar résistant au platine, MIRASOL)