[A22-37] Pembrolizumab (oesophageal or gastroesophageal junction carcinoma) – Addendum to Commission A21-144

Last updated 05.05.2022

Project no.:
A22-37

Commission:
Commission awarded on 30.03.2022 by the Federal Joint Committee (G-BA).

Report type:
Addendum

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

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:

Unchanged after addendum:

  • 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
Note:

If the need for additional work on a project commissioned by the G-BA arises during consultations, then IQWiG presents a report in the form of an "addendum". The G-BA subsequently decides on the extent of the added benefit, thus completing the early benefit assessment.

Federal Joint Committee (G-BA)

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

G-BA documents on this decision

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