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Dossier assessment

Pembrolizumab (urothelial cancer, first line) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A24-99
Last updated

Report documents

  1. Extract of dossier assessment

    Pembrolizumab (urothelial cancer, first line) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 420 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-99_en
    Download file : Extract of dossier assessment (PDF document, 420 kB, EN, not accessible)

  2. Dossier assessment

    Pembrolizumab (urothelial cancer, first line) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 849 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-99
    Download file : Dossier assessment (PDF document, 849 kB, DE, not accessible)

Dossier assessment

Indication:

First-line treatment of adult patients with unresectable or metastatic urothelial carcinoma

Result of dossier assessment:
  • Patients for whom cisplatin-based therapy is a suitable treatment option: hint of non-quantifiable added benefit.
  • Patients for whom cisplatin-based therapy is not a suitable treatment option: hint of major added benefit.
  • Patients for whom cisplatin-based and carboplatin-based therapy is not a suitable treatment option: added benefit not proven.

Press releases

Enfortumab vedotin plus pembrolizumab in advanced bladder cancer: hint of major added benefit

Patients for whom cisplatin-based therapy is unsuitable live significantly longer with the new drug combination than with previous therapy options.
Press release

Additional information

Federal Joint Committee (G-BA)

2025-04-03 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A24-99
Commission
Commission awarded on 24.09.2024 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/A24-99_en

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