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Zolbetuximab

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IDDRUG-ZOLBETUXIMAB
TipoFármaco
Alegais
AçúcarЗольбетуксимаб
Estadoreviewed 2026-04-30 | pending_clinical_signoff
DoençasDIS-GASTRIC
FontesSRC-ESMO-GASTRIC-2024 SRC-NCCN-GASTRIC-2025

Fatos sobre as drogas

ClasseAnticorpo monoclonal anti-CLDN18.2 quimérico IgG1
MecanismoChimeric 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 típicaLoading 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.
Ucrânia registadaFalso
NSZU reembolsadoFalso
Ucrânia verificada pela última vez2026-04-30

Notas

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.

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