[A25-26] Capivasertib (breast cancer) – Addendum to Project A24-105

Last updated 03.04.2025

Project no.:
A25-26

Commission:
Commission awarded on 12.02.2025 by the Federal Joint Committee (G-BA).

Report type:
Addendum

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Cancer

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

Note:

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.

DOI:

https://doi.org/10.60584/A25-26