Acalabrutinib granted Breakthrough Therapy Designation for the Treatment of Mantle Cell Lymphoma

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Acalabrutinib is a highly-selective, potent Bruton tyrosine kinase (BTK) inhibitor being evaluated for the treatment of multiple B-cell cancers.

The Breakthrough Therapy Designation is designed to expedite the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which demonstrate substantial improvement on a clinically-significant endpoint over available medicines and when there is significant unmet medical need.

About mantle cell lymphoma

Mantle cell lymphoma (MCL) is an aggressive B-cell non-Hodgkin lymphoma (NHL) with poor prognosis.  MCL accounts for approximately 3% to 6% of new NHL cases in Western countries each year.  The median age at diagnosis is 68 years, with a 3:1 male predominance.1,2,3

About Acalabrutinib

Acalabrutinib is an inhibitor of Bruton tyrosine kinase. Acalabrutinib was granted Orphan Drug Designation by the FDA for the treatment of patients with MCL. The drug works by permanently binding BTK, which is part of a chain of proteins that relays growth signals from the surface of B cells to genes in the cell nucleus enabling cancer cells to survive and grow. Drugs that block BTK stop the flow of these growth signals and the B cells die. Unlike Imbruvica™ (ibrutinib), the first BTK approved data reported from a clinical study suggests that acalabrutinib may more selectively block the BTK pathway and avoid some known side effects.4


  1. Leukemia & Lymphoma Society. Mantle Cell Lymphoma Facts. Accessed June 2017
  2. Cheah CY, Seymour JF, Wang M. Mantle Cell Lymphoma. Journal of Clinical Oncology 34, no. 11 (April 2016) 1256-1269.
  1. Hoster E, Klapper W et al. Confirmation of the Mantle-Cell Lymphoma International Prognostic Index in Randomized Trials of the European Mantle-Cell Lymphoma Network. Journal of Clinical Oncology 2014;32:1338-1346.

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