Dossier assessment

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

Status
Status: Commission completed
Project no.
A20-43
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, 691 kB, EN, not accessible
  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

Dossier assessment

Indication:

Adults with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease

Result of dossier assessment:

Indication of considerable added benefit

Press releases

Darolutamide in prostate cancer: indication of considerable added benefit

Advantages in overall survival, symptoms and health-related quality of life

Project details

Project no.
A20-43
Commission
Commission awarded on 30.04.2020 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 (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.

Connected Projects

  1. Addendum

    Darolutamide (prostate cancer) - Addendum to Commission A20-43

    Project no.
    A20-84
    Last updated

    Status: Commission completed

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