Addendum
Elacestrant (breast cancer) – Addendum to Project A23-104
Report documents
-
Addendum
Elacestrant (breast cancer) – Addendum to Project A23-104
Dossier assessment
Indication:
Postmenopausal women, and men, with oestrogen receptor positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor
Result of dossier assessment:
after addendum now:
- Postmenopausal women with 1 prior line of endocrine therapy in the advanced/metastatic stage: added benefit not proven
- Postmenopausal women with 2 prior lines of endocrine therapy in the advanced/metastatic stage: indication of considerable added benefit
- Men: added benefit not proven
Additional information
Federal Joint Committee (G-BA)
2024-05-02 A G-BA decision was published.
Project details
- Project no.
- A24-30
- Commission
- Commission awarded on 12.03.2024 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/A24-30_en
Connected Projects
-
Dossier assessment
Elacestrant (breast cancer; = 1 prior therapy) – Benefit assessment according to §35a Social Code Book V
Status: Commission completed