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FDA Grants Acalabrutinib Breakthrough Designation in MCL

Jason Harris
Published: Tuesday, Aug 01, 2017

The FDA has granted acalabrutinib a breakthrough therapy designation for patients with previously-treated mantle cell lymphoma (MCL), according to AstraZeneca, the manufacturer of the highly selective, potent BTK inhibitor.


  1. Awan FT, Schuh A, MD PhD, Brown JR, et al. Acalabrutinib monotherapy in patients with ibrutinib intolerance: Results from the phase 1/2 ACE-CL-001 clinical study. Presented at: American Society of Hematology 58th Annual Meeting; December 3-6, 2016; San Diego, CA. Abstract 638.
  2. Hillmen P, Schuh A, Eyre TA, et al. Acalabrutinib Monotherapy in Patients with Richter Transformation from the Phase 1/2 ACE-CL-001 Clinical Study. 58th ASH Annual Meeting and Exposition; San Diego, California; December 2-6, 2016. Abstract 60.

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