Acalabrutinib is used in selected adult B-cell malignancies. Approved indications differ between jurisdictions and can change as regulatory authorities review additional evidence.
Chronic lymphocytic leukemia
Current U.S. CALQUENCE labeling indicates acalabrutinib for adult patients with chronic lymphocytic leukemia (CLL). The same U.S. indication includes small lymphocytic lymphoma (SLL).
European authorization includes previously untreated CLL, where Calquence may be used alone or in combination with obinutuzumab, as well as specified combination regimens involving venetoclax, with or without obinutuzumab. It is also authorized as monotherapy for adults with CLL who have received at least one prior therapy.
Mantle cell lymphoma
Current U.S. labeling includes:
- previously untreated MCL in adults who are ineligible for autologous hematopoietic stem-cell transplantation, when used with bendamustine and rituximab; and
- adult patients with MCL who have received at least one prior therapy.
The EMA authorizes Calquence for specified MCL settings, including previously untreated MCL in adults who cannot undergo autologous stem-cell transplantation and relapsed/refractory MCL in adults who have not previously received a BTK inhibitor.
Approved versus investigational use
Acalabrutinib has been studied in additional hematologic malignancies and treatment combinations. Clinical investigation does not automatically mean that a use is approved.
This website should therefore distinguish clearly between:
- regulatory-approved uses,
- clinical-trial research, and
- off-label use.
Off-label treatment decisions should not be promoted as established indications.
Treatment combinations
Depending on jurisdiction and disease setting, acalabrutinib can be used as monotherapy or with other anticancer medicines. Current EU information includes combinations with obinutuzumab, venetoclax and/or bendamustine plus rituximab in specified circumstances.