Acalabrutinib (4) – Calquence®
Chronic lymphocytic leukaemia, first-line treatment, in combination with venetoclax
Characteristics
| Start date | 01.07.2025 – Marketing authorisation: 02.06.2025 |
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| Resolution | 18.12.2025 |
| INN | Acalabrutinib |
| Brand name | Calquence® |
| Pharm. company | AstraZeneca GmbH |
| G-BA Procedure ID | D-1208 |
| ATC code | L01EL02 BTK inhibitors (L01EL) |
| ICD-10 codes (AIS) | C91.10Chronic lymphocytic leukemia of B-cell type with failed remission, C91.11Chronic lymphocytic leukemia of B-cell type in remission |
| Alpha-ID codes (AIS) | I25521CLL (chronic lymphocytic leukemia), I31079CLL (chronic lymphocytic leukemia) in complete remission |
| Therapeutic area | Oncological diseases |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
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Calquence in combination with venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Erwachsene mit nicht vorbehandelter chronischer lymphatischer Leukämie (CLL) |
Studies and Results
- Clinical trials
- The AMPLIFY trial is an open-label, multicentre, randomised, controlled Phase III trial that has been ongoing since February 2019, in which acalabrutinib + venetoclax (AV) or acalabrutinib + venetoclax + obinutuzumab (AVO) were compared with a chemoimmunotherapy regimen (either fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab).
Adults with previously untreated chronic lymphocytic leukaemia (CLL)
- The additional benefit is not proven.
- The chemoimmunotherapies used in the comparator arm of the AMPLIFY study (fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab) do not correspond to the appropriate comparator therapy as defined by the G-BA. Consequently, the AMPLIFY study submitted by the pharmaceutical manufacturer is not suitable for demonstrating the additional benefit of acalabrutinib in combination with venetoclax.
Courtesy translation only, please refer to the German original.
Associated procedures
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