BRIEF—Calquence wins accelerated approval for mantle cell lymphoma

The UK’s AstraZeneca has been handed accelerated approval in the USA for its Calquence (acalabrutinib) for adults with mantle cell lymphoma.

The decision was based on data from the pivotal Phase II ACE-LY-004 trial, which showed an 80% overall response rate and a 40% complete response rate.

FDA oncology director Richard Pazdur said: “For patients who have not responded to treatment or have relapsed, Calquence provides a new treatment option that has shown high rates of response for some patients in initial studies.”

The application has been granted priority review and breakthrough therapy designations, as well as orphan drug designation.

MCL is an aggressive B-cell non-Hodgkin lymphoma with poor prognosis.