CALQUENCE® (acalabrutinib) granted Priority Review in the US for patients with untreated mantle cell lymphoma
AstraZeneca PLC - American Depositary Shares (AZN)
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Source: Business Wire
Based on ECHO Phase III trial which demonstrated CALQUENCE combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapySubmission to be reviewed under Project Orbis WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca’s supplemental New Drug Application (sNDA) for CALQUENCE® (acalabrutinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance.1 The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the first quarter of 2025.MCL is a rare and typically aggressive form of non-Hodgkin lymphoma (NHL), resulting when
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