Addendum

Pembrolizumab (oesophageal or gastroesophageal junction carcinoma) – Addendum to Commission A21-144

Status
Status: Commission completed
Project no.
A22-37
Last updated

Report documents

  1. Addendum

    Pembrolizumab (oesophageal or gastroesophageal junction carcinoma) – Addendum to Commission A21-144

    published on
    Document type
    PDF document, 5 MB, EN, 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:

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

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.
A22-37
Commission
Commission awarded on 30.03.2022 by the Federal Joint Committee (GBA).
Report type
Addendum
Status
Commission completed
Department/Division
Drug Assessment
Topic
Cancer
Note

If the need for additional work on a project commissioned by the GBA arises during consultations, IQWiG submits an addendum. The subsequent decides on the extent of the added benefit concludes the early benefit assessment.

Connected Projects

  1. Dossier assessment

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

    Project no.
    A21-144
    Last updated

    Status: Commission completed

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