Acalabrutinib receives approval in Europe for the treatment of CLL

On November 9, 2020, the next generation Bruton’s tyrosine kinase (BTK) inhibitor, acalabrutinib, was approved in the European Union for the treatment of adult patients with chronic lymphocytic leukemia (CLL).

Positive results from both the ELEVATE-TN and ASCEND studies, evaluating acalabrutinib in patients with treatment-naïve and relapsed/refractory (R/R) CLL, respectively, formed the basis of this approval. Acalabrutinib formerly received a positive opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) in July 2020, and U.S. Food and Drug Administration (FDA) approval for the treatment of both CLL and small lymphocytic lymphoma in November 2019.

Refinement of BTK inhibitor therapy with next generation agents like acalabrutinib promise to improve patient quality of life in the CLL setting, and this approval represents a step in the right direction to achieving a tolerable, chemotherapy-free option for patients with both treatment-naïve and R/R disease.