[A22-132] Zanubrutinib (chronic lymphocytic leukaemia, relapsed/refractory) – Benefit assessment according to §35a Social Code Book V
Last updated 15.03.2023
Project no.:
A22-132
Commission:
Commission awarded on 12.12.2022 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Cancer
Indication:
Patients with relapsed/refractory chronic lymphocytic leukaemia
Result of dossier assessment:
- who have not yet received a Bruton tyrosine kinase (BTK) inhibitor and/or B-cell lymphoma-2 (BCL-2) inhibitor
< 65 years: hint of major added benefit
≥ 65 years: hint of minor added benefit - after prior therapy with at least one BTK inhibitor: added benefit not proven
- after prior therapy with at least one BCL-2 inhibitor: added benefit not proven
- after prior therapy with at least one BTK inhibitor and one BCL-2 inhibitor: added benefit not proven
Note:
After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.
| Project no. | Title | Status |
|---|---|---|
| A22-131 | Zanubrutinib (marginal zone lymphoma) – Benefit assessment according to §35a Social Code Book V | Commission completed |
| A22-130 | Zanubrutinib (chronic lymphocytic leukaemia, first line) – Benefit assessment according to §35a Social Code Book V | Commission completed |
| A21-169 | Zanubrutinib (Waldenström macroglobulinaemia) - Benefit assessment according to §35a Social Code Book V | Commission completed |
| A23-130 | Zanubrutinib (follicular lymphoma) – Benefit assessment according to §35a Social Code Book V | Commission completed |