Dossier assessment

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

Status
Status: Commission completed
Project no.
A18-72
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 166 kB, EN, not accessible
  2. Dossier assessment

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

    published on
    Document type
    PDF document, 1 MB, DE, not accessible

Dossier assessment

Indication:

Women with HR-positive, HER2-negative locally advanced or metastatic breast cancer

Result of dossier assessment:

Initial endocrine therapy in postmenopausal women: indication of lesser benefit in comparison with appropriate comparator therapy. Subsequent endocrine therapy and/or pre- or perimenopausal women: added benefit not proven due to a lack of study data.

Additional information

Federal Joint Committee (G-BA)

2019-05-02 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A18-72
Commission
Commission awarded on 29.10.2018 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.

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