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Dossier assessment

Pembrolizumab (oesophageal cancer) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A21-144
Last updated

Report documents

  1. Extract of dossier assessment

    Pembrolizumab (oesophageal cancer) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 1 MB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 1 MB, EN, not accessible)

  2. Dossier assessment

    Pembrolizumab (oesophageal cancer) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 3 MB, DE, not accessible
    Download file : Dossier assessment (PDF document, 3 MB, DE, not accessible)

Dossier assessment

Indication:

First-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction adenocarcinoma in adults whose tumours express programmed cell death ligand 1 (PD-L1) (combined positive score [CPS] ≥ 10)

Result of dossier assessment:
  • Adult patients with locally advanced or metastatic squamous cell carcinoma of the oesophagus that cannot be treated curatively and whose tumours express PD-L1 (CPS ≥ 10); first-line treatment: hint of major added benefit
  • Adult patients with locally advanced or metastatic HER2-negative adenocarcinoma of the oesophagus or of the gastroesophageal junction that cannot be treated curatively and whose tumours express PD-L1 (CPS ≥ 10); first-line treatment: added benefit not proven
  • Adult patients with locally advanced or metastatic HER2-positive adenocarcinoma of the oesophagus that cannot be treated curatively and whose tumours express PD-L1 (CPS ≥ 10); first-line treatment: added benefit not proven

Press releases

Pembrolizumab in combination with chemotherapy: Major added benefit in advanced squamous cell carcinoma of the oesophagus

Median survival time of affected patients was 14 months compared to nine in the control group. However, an added benefit is not proven for patients with advanced adenocarcinoma.
Press release

Additional information

Federal Joint Committee (G-BA)

2022-05-05 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A21-144
Commission
Commission awarded on 15.12.2021 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 2022-02-15.

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