[A25-69] Datopotamab deruxtecan (breast cancer) – Benefit assessment according to §35a Social Code Book V
Last updated 20.11.2025
Project no.:
A25-69
Commission:
Commission awarded on 28.05.2025 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Topic:
Cancer
Adults with unresectable or metastatic HR-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting
- Patients with HER2-0 breast cancer, one line of chemotherapy in the advanced setting: added benefit not proven
- Patients with HER2-low breast cancer, one line of chemotherapy in the advanced setting: added benefit not proven
- Patients with HER2-0 or HER2-low breast cancer, at least 2 lines of chemotherapy in the advanced setting: 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/A25-69
| Project no. | Title | Status |
|---|---|---|
| A25-130 | Datopotamab deruxtecan (breast cancer) – Addendum to Project A25-69 | Commission completed |
Federal Joint Committee (G-BA)
2025-11-2025 A G-BA decision was published.