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, Gastric and GEJ adenocarcinoma
DrugBiomarker requirementRegimenSettingConditions
CLDN18.2-positive1
Claudin (CLDN) 18.2 positive, HER2-negative
+ fluoropyrimidine- and platinum-containing chemotherapy
1L
advanced
None

4 approvals for Gastric/GEJ need no biomarker and apply whatever the result. All approvals for Gastric/GEJ

See also

Label wording1

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Zolbetuximab (Vyloy)
    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).