[A21-52] Acalabrutinib (previously untreated chronic lymphocytic leukaemia) - Addendum to Commission A20-103

Last updated 04.06.2021

Project no.:
A21-52

Commission:
Commission awarded on 27.04.2021 by the Federal Joint Committee (G-BA).

Report type:
Addendum

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Cancer

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.

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.

Federal Joint Committee (G-BA)

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

G-BA documents on this decision

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