[A21-53] Acalabrutinib (previously untreated chronic lymphocytic leukaemia; combination with obinutuzumab) - Addendum to Commission A20-104
Last updated 04.06.2021
Project no.:
A21-53
Commission:
Commission awarded on 27.04.2021 by the Federal Joint Committee (G-BA).
Report type:
Addendum
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Cancer
Adult patients with previously untreated chronic lymphocytic leukaemia (CLL)
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.
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.
| Project no. | Title | Status |
|---|---|---|
| A20-104 | Acalabrutinib (chronic lymphocytic leukaemia; combination with obinutuzumab) - Benefit assessment according to §35a Social Code Book V | Commission completed |
Federal Joint Committee (G-BA)
2021-06-04: A G-BA decision was published.