ARTICLE | Clinical News
AZ's acalabrutinib gets Priority Review for MCL
August 4, 2017 4:46 PM UTC
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...
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