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Dossier assessment

Abemaciclib (breast cancer; adjuvant treatment) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A26-17
Last updated

Report documents

  1. Extract of dossier assessment

    Abemaciclib (breast cancer; adjuvant treatment) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 691 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A26-17_en
    Download file : Extract of dossier assessment (PDF document, 691 kB, EN, not accessible)

  2. Dossier assessment

    Abemaciclib (breast cancer; adjuvant treatment) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 807 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A26-17
    Download file : Dossier assessment (PDF document, 807 kB, DE, not accessible)

Drug assessment at a glance

  1. Drug assessment at a glance

    Abemaciclib (breast cancer; adjuvant treatment) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 377 kB, EN, not accessible
    Download file : Drug assessment at a glance (PDF document, 377 kB, EN, not accessible)

Dossier assessment

Indication:

Adjuvant treatment of patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive early breast cancer at high risk of recurrence

Result of dossier assessment:
  • Premenopausal women: added benefit not proven
  • Postmenopausal women: added benefit not proven

Additional information

Federal Joint Committee (G-BA)

20-08-2026 A G-BA decision was published.
G-BA documents on this decision

Project details

Project no.
A26-17
Commission
Commission awarded on 02.03.2026 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/A26-17_en

Connected Projects

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  10. Addendum

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