FDA grants priority review to AstraZeneca's filing for BTK inhibitor acalabrutinib in mantle cell ly

AstraZeneca announced Wednesday that the FDA accepted and granted priority review to an application seeking approval of acalabrutinib in patients with relapsed/refractory mantle cell lymphoma (MCL) who have received at least one prior therapy. The company, which is developing the BTK inhibitor with Acerta Pharma, in which it holds a majority stake, indicated that the target action date for the filing is in the first quarter of 2018.

The submission is based on results from the Phase II ACE-LY-004 trial, which evaluated the safety and efficacy of acalabrutinib in patients with relapsed/refractory MCL who have received at least one prior therapy. AstraZeneca noted that data from the study will be submitted for presentation at an upcoming medical meeting.

On Tuesday, AstraZeneca announced that the FDA granted breakthrough therapy designation for acalabrutinib for the treatment of patients with MCL who have received at least one prior therapy. The drug was previously awarded orphan drug designation by the agency in this indication.

AstraZeneca is investigating acalabrutinib as both monotherapy and combination therapy in a broad range of blood cancers and solid tumours, including the Phase III ACE-LY-308 study as a first-line treatment for patients with MCL.