[A25-130] Datopotamab deruxtecan (breast cancer) – Addendum to Project A25-69
Last updated 20.11.2025
Project no.:
A25-130
Commission:
Commission awarded on 07.10.2025 by the Federal Joint Committee (G-BA).
Report type:
Addendum
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: after addendum now: hint of a non-quantifiable added benefit
- Patients with HER2-low breast cancer, one line of chemotherapy in the advanced setting: unchanged after addendum: added benefit not proven
- Patients with HER2-0 or HER2-low breast cancer, at least 2 lines of chemotherapy in the advanced setting: unchanged after addendum: added benefit not proven
If the need for additional work on a project commissioned by the G-BA arises during consultations, then IQWiG presents a report in the form of an "addendum". The G-BA subsequently decides on the extent of the added benefit, thus completing the early benefit assessment.
https://doi.org/10.60584/A25-130
| Project no. | Title | Status |
|---|---|---|
| A25-69 | Datopotamab deruxtecan (breast cancer) – Benefit assessment according to §35a Social Code Book V | Commission completed |
Federal Joint Committee (G-BA)
20-11-2025 A G-BA decision was published.
G-BA documents on this decision