Dossier assessment

Elacestrant (breast cancer; = 1 prior therapy) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A23-104
Last updated

Report documents

  1. Extract of dossier assessment

    Elacestrant (breast cancer; = 1 prior therapy) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 483 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A23-104_en
  2. Dossier assessment

    Elacestrant (breast cancer; = 1 prior therapy) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 708 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/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:
  • Postmenopausal women: added benefit not proven
  • Men: added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2024-05-02 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A23-104
Commission
Commission awarded on 31.10.2023 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Cancer
Note

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://dx.doi.org/10.60584/A23-104_en

Connected Projects

  1. Addendum

    Elacestrant (breast cancer) – Addendum to Project A23-104

    Project no.
    A24-30
    Last updated

    Status: Commission completed

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