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Dossier assessment

Olaparib (breast cancer, adjuvant) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A22-89
Last updated

Report documents

  1. Extract of dossier assessment

    Olaparib (breast cancer, adjuvant) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 782 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 782 kB, EN, not accessible)

  2. Dossier assessment

    Olaparib (breast cancer, adjuvant) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 1 MB, DE, not accessible
    Download file : Dossier assessment (PDF document, 1 MB, DE, not accessible)

Dossier assessment

Indication:

Adult patients with germline BRCA-mutant, HER2-negative, high risk early breast cancer; after neoadjuvant or adjuvant chemotherapy; adjuvant treatment

Result of dossier assessment:

Indication of minor added benefit

Press releases

Early breast cancer: indication of minor added benefit of adjuvant olaparib

Adjuvant olaparib treatment of early breast cancer can prolong life and prevent recurrence. However, it often leads to side effects, some of which are serious.
Press release

Additional information

Federal Joint Committee (G-BA)

2023-02-16 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A22-89
Commission
Commission awarded on 25.08.2022 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.

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