Dossier assessment

Darolutamide (prostate cancer) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-106
Last updated

Report documents

  1. Extract of dossier assessment

    Darolutamide (prostate cancer) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 710 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-106_en
  2. Dossier assessment

    Darolutamide (prostate cancer) – 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/A25-106

Dossier assessment

Indication:

Adult men with metastatic hormone-sensitive prostate cancer

Result of dossier assessment:

Added benefit not proven

Project details

Project no.
A25-106
Commission
Commission awarded on 13.08.2025 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/A25-106_en

Connected Projects

  1. Dossier assessment

    Darolutamide (prostate cancer) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A23-21
    Last updated

    Status: Commission completed

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