Zolbetuximab
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-ZOLBETUXIMAB |
|---|---|
| Type | Médicament |
| Alias | VyloyЗольбетуксимаб |
| État | reviewed 2026-04-30 | pending_clinical_signoff |
| Maladies | DIS-GASTRIC |
| Sources | SRC-ESMO-GASTRIC-2024 SRC-NCCN-GASTRIC-2025 |
Faits sur les drogues
| Catégorie | Anticorps monoclonal anti-CLDN18.2 chimérique IgG1 |
|---|---|
| Mécanisme | Chimeric IgG1 monoclonal antibody targeting Claudin-18 isoform 2 (CLDN18.2), a tight-junction protein normally restricted to gastric mucosa but aberrantly retained in gastric/GEJ adenocarcinoma cells. Mechanisms: ADCC (NK cell-mediated via FcγRIIIa) and CDC (complement- dependent cytotoxicity). Combined with chemotherapy backbone (mFOLFOX6 in SPOTLIGHT, CAPOX in GLOW) for 1L HER2-negative CLDN18.2-positive (≥75% of tumor cells with 2+/3+ membranous staining) metastatic gastric / GEJ adenocarcinoma. |
| Dose typique | Loading dose 800 mg/m² IV cycle 1 day 1; maintenance 600 mg/m² IV q3w (with CAPOX) or q2w (with mFOLFOX6). Slow infusion: cycle 1 over ≥4 hours, subsequent cycles ≥2 hours. Pre-medication for nausea mandatory. Companion diagnostic VENTANA CLDN18 (43-14A) RxDx required before initiation. |
| Ukraine enregistrée | Faux |
| NSZU remboursé | Faux |
| Ukraine vérifiée pour la dernière fois | 2026-04-30 |
Notes
First-in-class anti-CLDN18.2 mAb. SPOTLIGHT (Shitara Lancet 2023): zolbetuximab + mFOLFOX6 vs mFOLFOX6 — mPFS 10.6 vs 8.7 mo (HR 0.75); mOS 18.2 vs 15.5 mo. GLOW (Shah Nat Med 2023): zolbetuximab + CAPOX vs CAPOX — mPFS 8.2 vs 6.8 mo (HR 0.69); mOS 14.4 vs 12.2 mo (HR 0.77). FDA approval Oct 2024. Cycle-1 nausea is the dominant tolerability problem — mitigated by slow infusion + triple-antiemetic prophylaxis (5-HT3 + NK1-RA + dex) + dose interruption / reduction protocol; tolerance generally improves cycles 2+. Bibliographic record SRC-SPOTLIGHT-SHITARA-2023 and SRC-GLOW are available; clinical claim linkage requires dual clinical sign-off.
Utilisé par
Protocole thérapeutique
REG-ZOLBETUXIMAB-CHEMO- Zolbetuximab + mFOLFOX6 (SPOTLIGHT) - 1L CLDN18,2-positif HER2-négatif gastrique/GEJ