Addendum

Acalabrutinib (previously untreated chronic lymphocytic leukaemia; combination with obinutuzumab) - Addendum to Commission A20-104

Status
Status: Commission completed
Project no.
A21-53
Last updated

Report documents

  1. Addendum

    Acalabrutinib (previously untreated chronic lymphocytic leukaemia; combination with obinutuzumab) - Addendum to Commission A20-104

    published on
    Document type
    PDF document, 951 kB, EN, not accessible

Dossier assessment

Indication:

Adult patients with previously untreated chronic lymphocytic leukaemia (CLL)

Result of dossier assessment:

Patients who have no 17p deletion or TP53 mutation and for whom treatment with FCR is an option: added benefit not proven.

Patients who have no 17p deletion or TP53 mutation and for whom treatment with FCR is not an option: hint of non-quantifiable added benefit.

Patients who have 17p deletion or TP53 mutation or for whom chemo-immunotherapy is not indicated for other reasons: added benefit not proven.

Additional information

Federal Joint Committee (G-BA)

2021-06-04: A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A21-53
Commission
Commission awarded on 27.04.2021 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

    Acalabrutinib (chronic lymphocytic leukaemia; combination with obinutuzumab) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A20-104
    Last updated

    Status: Commission completed

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