AstraZeneca's Calquence sNDA Gets FDA Priority Tag for Expanded Use

AstraZeneca (AZN) announced that the FDA has accepted the supplemental new drug application (sNDA), seeking approval for the expanded use of Calquence (acalabrutinib) in mantle cell lymphoma (MCL).The company is seeking approval for Calquence for the treatment of adult patients with previously untreated MCL, a rare and aggressive form of non-Hodgkin lymphoma. In the MCL indication, Calquence is currently approved for treating adult patients with MCL who have received at least one prior therapy in the United ...