BeiGene, Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for its investigational Bruton's tyrosine kinase (BTK) inhibitor, zanubrutinib, for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton's tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated in a broad pivotal clinical program globally as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Clinical trials of zanubrutinib include a fully-enrolled, global Phase 3 clinical trial in patients with Waldenstr m macroglobulinemia (WM) comparing zanubrutinib to ibrutinib, the currently only approved BTK inhibitor for WM; a global Phase 3 clinical trial in patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); a pivotal Phase 2 trial in patients with relapsed/refractory (R/R) follicular lymphoma in combination with GAZYVA (obinutuzumab); a Phase 3 trial comparing zanubrutinib to ibrutinib in patients with R/R CLL/SLL; and a global Phase 1 trial. In China, BeiGene has completed two pivotal Phase 2 clinical trials of zanubrutinib in patients with MCL and CLL/SLL and the enrollment in the pivotal Phase 2 clinical trials in patients with WM. Zanubrutinib has been granted Fast Track designation for the treatment of patients with WM and Breakthrough Therapy designation for the treatment of adult patients with MCL who have received at least one prior therapy by the U.S. Food and Drug Administration (FDA). The NDAs in China for R/R MCL and R/R CLL/SLL have been accepted by the China National Medical Products Administration (NMPA) and granted priority review.