Posted by Michael Wonder on 03 Aug 2017
US FDA accepts regulatory submission for acalabrutinib and grants priority review
2 August 2017 - AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the US FDA has accepted and granted priority review for the new drug application for acalabrutinib, a highly-selective, potent, Bruton tyrosine kinase inhibitor.
The NDA is based on results from the Phase II ACE-LY-004 clinical trial, which evaluated the safety and efficacy of acalabrutinib in patients with relapsed/refractory mantle cell lymphoma who have received at least one prior therapy.
This follows the FDA’s recent breakthrough therapy designation for acalabrutinib.
