[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

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:

  • 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:

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.

15.02.2022

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 ...

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Federal Joint Committee (G-BA)

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

G-BA documents on this decision

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