The US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to acalabrutinib for patients with mantle cell lymphoma (MCL) who have previously received at least 1 line of therapy.1

Acalabrutinib previously received Orphan Drug Designation from the FDA to treat patients with MCL, and from the European Commission to treat patients with chronic lymphocytic leukemia (CLL), MCL, and Waldenström macroglobulinemia.

The FDA granted breakthrough designation based on data from the phase 2 ACE-LY-004 trial ( Identifier: NCT02213926), for which researchers enrolled 124 patients with previously treated MCL.

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A previous clinical trial ( Identifier: NCT02029443) that investigated the effects of acalabrutinib in 61 patients with CLL demonstrated safety and efficacy. At a median follow-up of 14.3 months, patients exhibited an overall response rate of 95%.2

Acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, is being investigated in more than 25 clinical trials to treat multiple B cell and other cancers.

RELATED: Mantle Cell Lymphoma: Evaluating the Treatment Landscape

The FDA grants breakthrough therapy designation to medications that treat serious conditions and early analyses demonstrate clinical benefit. Treatments must also provide evidence for improvement on clinically significant endpoints over standard therapies, and must address unmet medical needs.


  1. Acalabrutinib granted breakthrough therapy designation by US FDA for the treatment of patients with mantle cell lymphoma [news release]. Gaithersburg, MD: AstraZeneca; August 1, 2017. Accessed August 1, 2017.
  2. Byrd J, Harrington B, O’Brien S, et al. Acalabrutinib (ACP-196) in relapsed chronic lymphocytic leukemia. N Engl J Med. 2016; 374:323-32.