Addendum
Capivasertib (breast cancer) – Addendum to Project A24-105
Report documents
-
Addendum
Capivasertib (breast cancer) – Addendum to Project A24-105
Dossier assessment
Indication:
Women and men with PIK3CA/AKT1/PTEN-mutated, ER-positive, HER2-negative, locally advanced or metastatic breast cancer
Result of dossier assessment:
after addendum now:
- Women after recurrence of the disease during or after (neo-)adjuvant endocrine therapy, no treatment to date in locally advanced or metastatic stage: hint of lesser benefit
- Men after recurrence of the disease during or after (neo-)adjuvant endocrine therapy, no treatment to date in locally advanced or metastatic stage: added benefit not proven
- Women with disease progression during or after endocrine therapy that occurred in the locally advanced or metastatic stage: proof of considerable added benefit
- Men with disease progression during or after endocrine therapy that occurred in the locally advanced or metastatic stage: added benefit not proven
Additional information
Federal Joint Committee (G-BA)
2025-04-03 A G-BA decision was published.
Project details
- Project no.
- A25-26
- Commission
- Commission awarded on 12.02.2025 by the Federal Joint Committee (GBA).
- Report type
- Addendum
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Cancer
- Note
-
If the need for additional work on a project commissioned by the GBA arises during consultations, IQWiG submits an addendum. The subsequent decides on the extent of the added benefit concludes the early benefit assessment.
- DOI
- https://doi.org/10.60584/A25-26_en
Connected Projects
-
Dossier assessment
Capivasertib (breast cancer) – Benefit assessment according to §35a Social Code Book V
Status: Commission completed