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The FDA grants acalabrutinib Priority Review for the possible treatment of relapsed/refractory Mantle Cell Lymphoma
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On 2nd August 2017, a New Drug Application (NDA) for acalabrutinib was granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL).
This announcement follows acalabrutinib being awarded Breakthrough Therapy Designation (BTD) only one day previously; read more here. Similar to the BTD submission, the NDA is supported partly by results from the phase II ACE-LY-004 trial (NCT02213926).
It is expected that the FDA will make a final approval decision for acalabrutinib in the setting of R/R MCL in early 2018.
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