3/30/2023 0 Comments Didi ximalaya linkdoc usIn addition, zanubrutinib is being tested in a global Phase 3 clinical trial as a first-line treatment for patients with chronic lymphocytic leukemia (CLL) and a Phase 2 clinical trial in patients with relapsed or refractory follicular lymphoma in combination with GAZYVA ® (obinutuzumab). BeiGene announced today that this global Phase 3 study has completed patient enrollment. In addition to the global Phase 1 trial of zanubrutinib, which enrolled 76 WM patients to date, zanubrutinib is also being tested in a global Phase 3 clinical trial in patients with WM comparing zanubrutinib to ibrutinib, a currently approved BTK inhibitor. A drug candidate with a Fast Track Designation may be eligible for more frequent communications with the FDA, for Accelerated Approval and Priority Review (if relevant criteria are met), and rolling review of the NDA. The FDA's Fast Track program is intended to expedite or facilitate the process for reviewing new drugs that are intended to treat a serious or life-threatening disease or condition for which there is no effective treatment and demonstrate the potential to address unmet medical needs for the condition. “We are hopeful that zanubrutinib, if approved, may represent a valuable and important treatment option for patients with WM.” We look forward to working closely with the FDA in the continuing development of zanubrutinib for the treatment of this disease,” commented John Oyler, co-founder, CEO and Chairman of BeiGene. “We believe zanubrutinib is a differentiated BTK inhibitor based on the depth and durability of responses observed in our ongoing global Phase 1 trial of zanubrutinib in WM patients. A final determination to submit the NDA will be made subsequent to the pre-NDA meeting with FDA after obtaining mature data from the study this fall. Based on BeiGene’s discussions with the FDA, internal review of available data from its global Phase 1 trial of zanubrutinib in patients with WM, and supported by the Fast Track Designation, BeiGene is preparing to submit in the first half of 2019 a New Drug Application (NDA) to pursue an accelerated approval of zanubrutinib for patients with WM based on results from the global Phase 1 study. Food and Drug Administration (FDA) for the treatment of patients with Waldenström macroglobulinemia (WM). and BEIJING, China, J(GLOBE NEWSWIRE) - (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that its investigational BTK inhibitor zanubrutinib has been granted Fast Track designation by the U.S. FDAĮnrollment Complete in Global Phase 3 Clinical Trial in WMĬAMBRIDGE, Mass.
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