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 ≥1 prior therapy. Data from the trial will be submitted for presentation at an upcoming medical meeting...