Acalabrutinib

Acalabrutinib in the glossary for Waldenström's macroglobulinemia

A second generation Bruton's tyrosine kinase inhibitor (BTKi)

Acalabrutinib is a second generation Bruton's tyrosine kinase inhibitor (BTKi) used to treat a range of B-cell malignancies. Acalabrutinib was approved for medical use in the United States (US) in 2017, and in the European Union (EU) in 2020. Acalabrutinib as a monotherapy or in combination with obinutuzumab (a humanized anti-CD20 monoclonal antibody) is licensed in the EU for the treatment of adults with previously untreated chronic lymphocytic leukemia (CLL) and CLL patients who have received at least one prior therapy. In the US, acalabrutinib is indicated for the treatment of adults with mantle cell lymphoma (MCL) who have received at least one prior therapy, and for the treatment of adults with CLL or small lymphocytic lymphoma (SLL). It is designated as an orphan medicinal product in both the EU and US for CLL/SLL, MCL, and Waldenström's macroglobulinemia, WM (Acalabrutinib SmPC).