Dossier assessment

Tislelizumab (oesophageal squamous cell carcinoma, first line) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A24-129
Last updated

Report documents

  1. Extract of dossier assessment

    Tislelizumab (Ösophaguskarzinom, fortgeschritten, Erstlinie) Nutzenbewertung gemäß § 35a SGB V

    published on
    Document type
    PDF document, 331 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-129_V1.1_en
  2. Dossier assessment

    Tislelizumab (Ösophaguskarzinom, fortgeschritten, Erstlinie) Nutzenbewertung gemäß § 35a SGB V

    published on
    Document type
    PDF document, 873 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-129_V1.1

Dossier assessment

Indication:

Adults with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma that is not treatable with curative intent, whose tumours express PD-L1 with a Tumour Area Positivity score ≥ 5%

Result of dossier assessment:
  • Patients with tumour cell PD-L1 expression ≥ 1% or a combined positive score (CPS) ≥ 10; first-line treatment: added benefit not proven
  • Patients with no tumour cell PD-L1 expression ≥ 1% and no CPS ≥ 10; first-line treatment: added benefit not proven

Project details

Project no.
A24-129
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.

The current version 1.1 of the Dossier assessment replaces version 1.0 published on 01.04.2025.

DOI

https://doi.org/10.60584/A24-129_V1.1_en

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