Zanubrutinib accepted for priority review by FDA

The US Food and Drug Administration has accepted the New Drug Application (NDA) for zanubrutinib for priority review for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, filed by China’s BeiGene (Nasdaq: BGNE).

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

“Zanubrutinib, a potent and selective BTK inhibitor designed to maximize BTK occupancy and minimize off-target effects, has shown promise as a potential treatment for a number of B-cell malignancies,” said Dr Jane Huang, chief medical officer, hematology, at BeiGene.