[A26-52] Zolbetuximab (gastric or gastro-oesophageal junction adenocarcinoma) – Benefit assessment according to §35a Social Code Book V

Last updated 17.08.2026

Project no.:
A26-52

Commission:
Commission awarded on 15.05.2026 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Cancer

Indication:

First-line treatment for adults with locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma with Claudin (CLDN) 18.2-positive tumours

Result of dossier assessment:
  • Patients with PD-L1 expression ≥ 1 (CPS): added benefit not proven
  • Patients with PD-L1 expression < 1 (CPS): hint of a minor added benefit
Note:

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.

DOI:

https://doi.org/10.60584/A26-52

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