BeiGene, Ltd. Receives U.S. FDA Breakthrough Therapy Designation for Zanubrutinib in Mantle Cell Lymphoma
January 14, 2019 at 04:34 pm
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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.
BeiGene, Ltd. is a global biotechnology company engaged in discovering and developing oncology treatments for cancer patients worldwide. The Company has discovered and developed three approved medicines, including BRUKINSA, a small molecule inhibitor of Brutonâs Tyrosine Kinase for the treatment of various blood cancers; TEVIMBRA (tislelizumab), an anti-PD-1 antibody immunotherapy for the treatment of various solid tumor and blood cancers; and pamiparib, a selective small molecule inhibitor of poly ADP-ribose polymerase 1 (PARP1) and PARP2. The Company has obtained approvals to market BRUKINSA in the United States, the People's Republic of China (China or the PRC), the European Union, the United Kingdom, Canada, Australia, and additional international markets; tislelizumab in the European Union and China; and pamiparib in China. It also focuses on commercializing cancer medicines, such as XGEVA, BLINCYTO, KYPROLIS, and others in China under an exclusive license from Amgen Inc.