[A21-153] Abemaciclib (breast cancer; combination with fulvestrant) - Benefit assessment according to §35a Social Code Book V

Last updated 01.03.2022

Project no.:

Commission awarded on 01.12.2021 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Commission completed

Drug Assessment

Application field:


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

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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