Calquence closer to first-line MCL approval

3 October 2024

AstraZeneca’s (LSE: AZN) supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the USA for the treatment of adults with previously untreated mantle cell lymphoma (MCL).

The Anglo-Swedish drugmaker’s filing is based on ECHO Phase III trial which demonstrated that a Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy.

The Prescription Drug User Fee Act date is anticipated during the first quarter of 2025.

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