Dossier assessment
Capivasertib (breast cancer) – Benefit assessment according to §35a Social Code Book V
Report documents
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Extract of dossier assessment
Capivasertib (breast cancer) – Benefit assessment according to §35a Social Code Book V
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Dossier assessment
Capivasertib (breast cancer) – Benefit assessment according to §35a Social Code Book V
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:
- Women 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
- 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: added benefit not proven
- 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.
- A24-105
- Commission
- Commission awarded on 01.10.2024 by the Federal Joint Committee (GBA).
- Report type
- Dossier assessment
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Cancer
- Note
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After completion of the assessment by IQWiG the Federal Joint Committee (GBA) 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 GBA website.
- DOI
- https://doi.org/10.60584/A24-105_en
Connected Projects
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Addendum
Capivasertib (breast cancer) – 2nd Addendum to Project A24-105
Status: Commission completed