Addendum

Abemaciclib (breast cancer; adjuvant treatment) - Addendum to Commission A22-51

Status
Status: Commission completed
Project no.
A22-96
Last updated

Report documents

  1. Addendum

    Abemaciclib (breast cancer; adjuvant treatment) - Addendum to Commission A22-51

    published on
    Document type
    PDF document, 456 kB, EN, not accessible

Dossier assessment

Indication:

Adjuvant treatment of patients with HR-positive, HER2-negative, node-positive early-stage breast cancer at high risk of recurrence

Result of dossier assessment:

Unchanged after addendum:

  • Premenopausal women: hint of minor added benefit
  • Postmenopausal women: added benefit not proven
  • Men: added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2022-10-20 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A22-96
Commission
Commission awarded on 06.09.2022 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.

Connected Projects

  1. Dossier assessment

    Abemaciclib (breast cancer) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A22-51
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Abemaciclib (breast cancer; adjuvant treatment) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A26-17
    Last updated

    Status: Commission completed

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