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# FDA Accepts AstraZeneca NDA for Acalabrutinib
- URL: https://www.fdaweb.com/fda-accepts-astrazeneca-nda-for-acalabrutinib/
- Published: 2017-08-02T12:00:00.000Z
- Updated: 2026-09-14T22:38:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139293

FDA has accepted for priority review an AstraZeneca NDA for acalabrutinib, a highly-selective Bruton tyrosine kinase inhibitor for treating patients with relapsed/refractory mantle cell lymphoma who have received at least one prior therapy. The submission is based on results from the Phase 2 ACE-LY-004 clinical trial. The company says the therapy had minimal off-target activity observed in pre-clinical trials. The agency has set a user fee review target date for the first quarter of 2018.