[A21-144] Pembrolizumab (oesophageal cancer) - Benefit assessment according to §35a Social Code Book V
Last updated 05.05.2022
Project no.:
A21-144
Commission:
Commission awarded on 15.12.2021 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Topic:
Cancer
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)
- 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
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.
The current version 1.1 of the dossier assessment replaces version 1.0 published on 2022-02-15.
Federal Joint Committee (G-BA)
2022-05-05 A G-BA decision was published.