Zolbetuximab

Zolbetuximab (Vyloy, Astellas Pharma Europe B.V.) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: CLDN18.2 (1).
Approved indications of Zolbetuximab
Biomarker requirementRegimenSettingConditions
Gastric and GEJ adenocarcinoma1
Claudin (CLDN) 18.2 positive, HER2-negative
+ fluoropyrimidine- and platinum-containing chemotherapy
1L
advanced
None
Full text of section 4.1 (therapeutic indications)

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).

Label history

5 changes to the Vyloy label since 2025, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes