CLDN18.2 in oesophageal cancer

1 EU-approved indication in oesophageal cancer needs a CLDN18.2 result: zolbetuximab (1st line, advanced).

Histology

Approved indications, Oesophageal cancer
DrugBiomarker requirementRegimenSettingConditions
CLDN18.2-positive1
Claudin (CLDN) 18.2 positive, HER2-negative
+ fluoropyrimidine- and platinum-containing chemotherapy
1L
advanced
Gastro-oesophageal junction adenocarcinoma only

4 approvals for Oesophageal need no biomarker and apply whatever the result. All approvals for Oesophageal

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).