FDA accepts NDA for zanubrutinib to treat mantle cell lymphoma

BeiGene, Ltd. announced that the FDA has accepted the company’s New Drug Application (NDA) for zanubrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

The FDA granted Priority Review for the NDA and has set a Prescription Drug User Fee Act (PDUFA) target action date of 27 February 2020. This follows the FDA’s Breakthrough Therapy designation for zanubrutinib in this setting earlier this year.