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Dossier assessment

Abemaciclib (breast cancer; combination with fulvestrant) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A21-153
Last updated

Report documents

  1. Extract of dossier assessment

    Abemaciclib (breast cancer; combination with fulvestrant) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 1 MB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 1 MB, EN, not accessible)

  2. Dossier assessment

    Abemaciclib (breast cancer; combination with fulvestrant) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 5 MB, DE, not accessible
    Download file : Dossier assessment (PDF document, 5 MB, DE, not accessible)

Dossier assessment

Indication:

Patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer

Result of dossier assessment:
  • Postmenopausal women, initial endocrine therapy: added benefit not proven
  • Postmenopausal women who received prior endocrine therapy; patients with visceral metastases: proof of a considerable added benefit
  • Postmenopausal women who received prior endocrine therapy; patients with non-visceral metastases: indication of minor benefit

Press releases

Criticism of study planning: patient-reported outcomes often recorded for far too short a time

Concise example: Abemaciclib in advanced breast cancer. Data on quality of life, symptoms and side effects that were recorded for too short a time impair the early benefit assessment.
Press release

Project details

Project no.
A21-153
Commission
Commission awarded on 01.12.2021 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.

Connected Projects

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    Abemaciclib (breast cancer; combination with an aromatase inhibitor) – Benefit assessment according to §35a Social Code Book V

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    Status: Commission completed

  6. Dossier assessment

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

    Project no.
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    Last updated

    Status: Commission completed

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