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Dossier assessment

Pembrolizumab (head and neck squamous cell carcinoma) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-148
Last updated

Report documents

  1. Extract of dossier assessment

    Pembrolizumab (head and neck squamous cell carcinoma) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 669 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-148_en
    Download file : Extract of dossier assessment (PDF document, 669 kB, EN, not accessible)

  2. Dossier assessment

    Pembrolizumab (head and neck squamous cell carcinoma) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 1 MB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-148
    Download file : Dossier assessment (PDF document, 1 MB, DE, not accessible)

Drug assessment at a glance

  1. Drug assessment at a glance

    Pembrolizumab (head and neck squamous cell carcinoma) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 275 kB, EN, not accessible
    Download file : Drug assessment at a glance (PDF document, 275 kB, EN, not accessible)

Dossier assessment

Indication:

Adult patients with resectable locally advanced head and neck squamous cell carcinoma whose tumours express programmed death-ligand 1 with a combined positive score ≥ 1

Result of dossier assessment:
  • Patients with a high postoperative risk profile for whom cisplatin-based therapy is suitable, or with a low postoperative risk profile; neoadjuvant and adjuvant therapy: hint of a minor added benefit
  • Patients with a high postoperative risk profile for whom cisplatin-based therapy is not suitable; neoadjuvant and adjuvant therapy: added benefit not proven

Additional information

Federal Joint Committee (G-BA)

21-05-2026 A G-BA decision was published.
G-BA documents on this decision

Project details

Project no.
A25-148
Commission
Commission awarded on 24.11.2025 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Cancer
Note

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.

DOI

https://doi.org/10.60584/A25-148_en

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