[A26-30] Imlunestrant (breast cancer) – Benefit assessment according to §35a Social Code Book V
Last updated 15.06.2026
Project no.:
A26-30
Commission:
Commission awarded on 13.03.2026 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Topic:
Cancer
Adults with oestrogen receptor-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating oestrogen receptor 1 mutation
- Women whose disease has progressed after (neo-)adjuvant endocrine therapy and who have not yet received treatment in the locally advanced or metastasised stage: added benefit not proven
- Men whose disease has progressed after (neo-)adjuvant endocrine therapy and who have not yet received treatment in the locally advanced or metastasised stage: added benefit not proven
- Women whose disease has progressed following endocrine therapy administered in the locally advanced or metastatic stage and for whom fulvestrant is the suitable therapy for the individual patient: hint of a minor added benefit
- Women whose disease has progressed following endocrine therapy administered in the locally advanced or metastatic stage and for whom treatments other than fulvestrant represent the suitable therapy for the individual patient: added benefit not proven
- Men whose disease has progressed following endocrine therapy administered in the locally advanced or metastatic stage: added benefit not proven
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.
https://doi.org/10.60584/A26-30