Calquence granted Priority Review in the US for patients with untreated mantle cell lymphoma
Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy. Submission to be reviewed under Project Orbis. 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