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Dossier assessment

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

Status
Status: Commission completed
Project no.
A26-52
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 287 kB, DE, not accessible
    Download file : Extract of dossier assessment (PDF document, 287 kB, DE, not accessible)

  2. Dossier assessment

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

    published on
    Document type
    PDF document, 4 MB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A26-52
    Download file : Dossier assessment (PDF document, 4 MB, DE, not accessible)

Dossier assessment

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

Project details

Project no.
A26-52
Commission
Commission awarded on 15.05.2026 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Cancer
Note

After completion of the assessment by IQWiG the Federal Joint Committee (GBA) 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 GBA website.

DOI

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

Connected Projects

  1. Dossier assessment

    Zolbetuximab (gastric or gastro-oesophageal junction adenocarcinoma, HER2-negative) – Assessment in accordance with § 35a Social Code Book (SGB) V (1), Sentence 11

    Project no.
    G24-32
    Last updated

    Status: Commission completed

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