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An expert panel hosted by
Customizing first-line BTK inhibitors for CLL
with Gilles Salles, Paolo Ghia, and Francesc Bosch
Wednesday, October 23, 2024
18:30-19:30 BST
This independent educational activity is supported by Pharmacyclics LLC, an AbbVie Company and Janssen Biotech. All content is developed independently by the faculty. The funder is allowed no influence on the content of this activity.
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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.
Expert Opinion
- AstraZeneca. Calquence granted US Breakthrough Therapy Designation for chronic lymphocytic leukaemia. Press release 14th August 2019. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/calquence-granted-us-breakthrough-therapy-designation-for-chronic-lymphocytic-leukaemia-14082019.html [Accessed August 15 2019]
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