Dossier assessment

Tislelizumab (gastric or gastroesophageal junction adenocarcinoma, HER2-negative) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A24-131
Last updated

Report documents

  1. Extract of dossier assessment

    Tislelizumab (gastric or gastroesophageal junction adenocarcinoma, HER2-negative) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 394 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-131_en
  2. Dossier assessment

    Tislelizumab (gastric or gastroesophageal junction adenocarcinoma, HER2-negative) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 934 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-131

Dossier assessment

Indication:

Adults with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma and tumour PD-L1 expression with a TAP (Tumour Area Positivity) score ≥ 5%, and

Result of dossier assessment:
  • tumour PD-L1 expression ≥ 1 (combined positive score; CPS) for first-line treatment: added benefit not proven
  • tumour PD-L1 expression < 1 (combined positive score; CPS) for first-line treatment: added benefit not proven

Project details

Project no.
A24-131
Commission
Commission awarded on 20.12.2024 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/A24-131_en

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