AZ's acalabrutinib gets Priority Review for MCL

AstraZeneca plc (LSE:AZN; NYSE:AZN) and Acerta Pharma B.V. (Oss, the Netherlands) said FDA accepted and granted Priority Review to an NDA for acalabrutinib (ACP-196) to treat relapsed or refractory mantle cell lymphoma (MCL). Its PDUFA date is in 1Q18. Acalabrutinib is a second-generation Bruton's tyrosine kinase (Btk) inhibitor.

The companies based the submission on data from the Phase II ACE-LY-004 trial evaluating acalabrutinib in relapsed or refractory MCL patients who have received at least one prior therapy. Data from the trial will be submitted for presentation at an upcoming medical meeting...