[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 (GBA).
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 (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.
Federal Joint Committee (G-BA)
2022-05-05 A G-BA decision was published.