[A25-104] Inavolisib (breast cancer) - Benefit assessment according to §35a Social Code Book V
Last updated 17.11.2025
Project no.:
A25-104
Commission:
Commission awarded on 11.08.2025 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Topic:
Cancer
Adult patients with PIK3CA-mutated, oestrogen receptor-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence during or within 12 months of completing adjuvant endocrine treatment
- Female patients < 65 years of age: indication of a minor added benefit
- Female patients ≥ 65 years of age: added benefit not proven
- Male patients: 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/A25-104