# CLDN18.2 in gastric and GEJ adenocarcinoma

1 EU-approved indication in gastric and GEJ adenocarcinoma needs a CLDN18.2 result: zolbetuximab (1st line, advanced).

## Approved indications

### CLDN18.2-positive

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Zolbetuximab](https://oncolabels.com/drugs/zolbetuximab) (Vyloy) | Claudin (CLDN) 18.2 positive, HER2-negative | + fluoropyrimidine- and platinum-containing chemotherapy | 1st line, advanced | - |

## Label wording

- **Zolbetuximab** (Vyloy), Gastric and GEJ adenocarcinoma, 1st line, advanced: “Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive (see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/vyloy-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/tumours/gastric-and-gej-adenocarcinoma/cldn18-2