The FDA grants acalabrutinib Breakthrough Therapy Designation for relapsed/refractory Mantle Cell Lymphoma

On 1st August 2017, acalabrutinib was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Mantle Cell Lymphoma (MCL) who have received one or more previous therapies.

AstraZeneca’s acalabrutinib is an oral, irreversible Bruton’s Tyrosine Kinase (BTK) inhibitor and prevents activation of the B-Cell Receptor (BCR) signaling pathway.

The BTD is based on data from the acalabrutinib development program investigating monotherapy and combination regimens in a wide range of solid and hematological tumors; and includes data from the ACE-LY-004 trial (NCT02213926). This is a phase II, open-label study aiming to determine the safety and efficacy of acalabrutinib in patients with Relapsed/Refractory (R/R) MCL. This trial is estimated to complete in January 2018 and has an estimated enrolment of 124 patients. The primary endpoint is Overall Response Rate (ORR).

Trials currently recruiting patients investigating acalabrutinib include a phase III trial of bendamustine and rituximab alone or in combination with acalabrutinib in newly diagnosed MCL (NCT02972840), a phase II study of acalabrutinib in R/R Chronic Lymphocytic Leukemia (CLL) and newly diagnosed del(17p) CLL (NCT02337829), and a broader phase I/II trial of acalabrutinib combined with the PI3K inhibitor ACP-319 in B-cell malignancies (NCT02328014).

  1. Digital Look. FDA grants 'breakthrough therapy designation' to AstraZeneca for acalabrutinib. 2017 Aug 01. [Accessed 2017 Aug 01].
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