AstraZeneca Seeks Expanded Use For Blood Cancer Drug Calquence, FDA Grants Priority Review

On Thursday, the FDA accepted and granted Priority Review to AstraZeneca Plc’s (NASDAQ:AZN) supplemental marketing application for Calquence (acalabrutinib) for adult patients with previously untreated mantle cell lymphoma (MCL).

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 B-lymphocytes mutate into malignant cells within a region of the lymph node known as the mantle zone.

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