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.
- OncLive. FDA Awards Acalabrutinib Priority Review in MCL. 2017 Aug 02. http://www.onclive.com/web-exclusives/fda-awards-acalabrutinib-priority-review-in-mcl. [Accessed 2017 Aug 04].