Acalabrutinib (6) – Calquence®
Mantle cell lymphoma, no prior BTKi treatment, relapsed or refractory, monotherapy
Characteristics
| Start date | 01.07.2025 – Marketing authorisation: 02.05.2025 |
|---|---|
| Resolution | 18.12.2025 |
| INN | Acalabrutinib |
| Brand name | Calquence® |
| Pharm. company | AstraZeneca GmbH |
| G-BA Procedure ID | D-1210 |
| ATC code | L01EL02 BTK inhibitors (L01EL) |
| Therapeutic area | Oncological diseases |
| Reason for procedure | New therapeutic indication |
Studies and Results
- Clinical trials
- The ACE-LY-004 trial was a single-arm, completed Phase II trial conducted from 2 March 2015 to 4 December 2020 in North America, Europe and Australia.
Adults with relapsed or refractory mantle cell lymphoma who have not received prior treatment with a BTK inhibitor
- An additional benefit is not proven.
- Due to its single-arm design, the ACE-LY-004 study does not allow for a comparison with the appropriate comparator therapy and is therefore not suitable for assessing the additional benefit of acalabrutinib as monotherapy.
Courtesy translation only, please refer to the German original.
Associated procedures
<< List of all resolutions