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 European Union (EU) in 2020 ^1,2. 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 ^2,3. It is designated as an orphan medicinal product in the EU for CLL/SLL, MCL, and Waldenström's macroglobulinemia.⁴. Acalabrutinib is approved for use in Australia for the treatment of CLL/SLL and MCL. ⁵

Glossary overview

References

1.AstraZeneca press release 2020. Calquence approved in the EU for the treatment of chronic lymphocytic leukaemia. https://www.astrazeneca.com/media-centre/press-releases/2020/calquence-approved-in-the-eu-for-cll.html. Accessed November 12th, 2021.

2.Abbas HA and Wierda WG. Acalabrutinib: A Selective Bruton Tyrosine Kinase Inhibitor for the Treatment of B-Cell Malignancies. Frontiers in Oncology 2021: 11.

3.Calquence SmPC. Available from; https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf. Accessed November 12th, 2021.

4.AstraZeneca Press Release 2016. Available from; https://www.astrazeneca.com/media-centre/press-releases/2016/acalabrutinib-recommended-for-orphan-drug-designation-in-europe-for-three-indications-25022016.html. Accessed November 12th, 2021.

5.Australian Public Assessment Report for Acalabrutinib. Avaialble from; https://www.tga.gov.au/node/903794. Accessed November 12th, 2021

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