FDA grants Breakthrough Therapy Designation to acalabrutinib for adult patients with CLL

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.

  1. AstraZeneca. Calquence granted US Breakthrough Therapy Designation for chronic lymphocytic leukaemia. Press release 14th August 2019. [Accessed  August 15 2019]

Expert Opinion

Download this article:

You can now download this article in Adobe PDF® format.

Download as PDF
Was this article informative? Thank you for your feedback!