On the 14th of August 2019 the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for acalabrutinib as a monotherapy treatment for adult patients with chronic lymphocytic leukaemia (CLL).
Acalabrutinib, is an inhibitor of Bruton tyrosine kinase (BTK) involved in pathways regulating B-cell proliferation, chemotaxis, and adhesion. The decision was based on positive results from the interim analyses of two phase III clinical trials, ELEVATE-TN and ASCEND.
The drug was previously granted accelerated approval for the treatment of adult patients with R/R mantle cell lymphoma (MCL). Acalabrutinib is also currently being evaluated, as a monotherapy and in combination, in 26 clinical trials in indications including CLL, MCL, diffuse large B-cell lymphoma, Waldenström macroglobulinaemia, follicular lymphoma, and multiple myeloma.