FDA Grants BeiGene’s Lymphoma Treatment Priority Review

BeiGene, Ltd. has announced that the U.S. Food and Drug Administration (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 February 27, 2020. This follows the FDA’s Breakthrough Therapy designation for zanubrutinib in this setting earlier this year.

"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 Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene. "We are proud to have submitted our first NDA in the U.S., which has now been accepted and designated for Priority Review by the FDA for the treatment of patients with relapsed/refractory mantle cell lymphoma, an aggressive form of lymphoma. We are conducting a broad global clinical development program for zanubrutinib that currently consists of eight Phase 3 or potentially registration-enabling trials, including two head-to-head comparative trials, with approximately 1,500 patients treated across all programs."

The NDA data package includes data from the global Phase 1/2 trial (NCT02343120) in patients with B-cell lymphomas and an aggregate of 123 patients in the multicenter Phase 2 trial of zanubrutinib in patients with relapsed or refractory (R/R) MCL in China (NCT03206970), as well as safety data on 641 patients from five clinical trials, and non-clinical data.

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