[A24-30] Elacestrant (breast cancer) – Addendum to Project A23-104

Last updated 02.05.2024

Project no.:
A24-30

Commission:
Commission awarded on 12.03.2024 by the Federal Joint Committee (G-BA).

Report type:
Addendum

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Cancer

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
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/A24-30_en

Federal Joint Committee (G-BA)

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

G-BA documents on this decision

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