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# BeiGene NDA for Mantle Cell Lymphoma Drug
- URL: https://www.fdaweb.com/beigene-nda-for-mantle-cell-lymphoma-drug/
- Published: 2019-08-22T12:00:00.000Z
- Updated: 2026-09-15T01:45:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144838

FDA has accepted for priority review a BeiGene NDA for zanubrutinib for treating patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. The submission includes data from a global Phase 1/2 trial (NCT02343120) in patients with B-cell lymphomas and an aggregate of 123 patients in a multicenter Phase 2 trial of zanubrutinib in patients with relapsed or refractory MCL in China (NCT03206970). It also includes safety data on 641 patients from five clinical trials. The agency has set a user fee review action target of 2/27/2020.

The company describes zanubrutinib as a potent and selective BTK inhibitor designed to maximize BTK occupancy and minimize off-target effects, and as showing promise as a potential treatment for a number of B-cell malignancies. “We are conducting," it says, "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.”