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The U.S. Food and Drug Administration (FDA) has accepted an application from BRUKINSA (zanubrutinib) for a new drug (sNDA) to treat adult patients with Waldenström globulinemia (WM), the company announced today.
Jane Huang, chief medical officer of hematology at Baiji Shenzhou, said: "Waldenström globulinemia is a rare disease with a very low incidence.
recent years, BTK inhibitors have changed the treatment of WM, but reactions vary from subsype patient to subsype, and side effects of BTK inhibitors remain a serious problem.
we look forward to continuing to communicate with the FDA in the coming months and hope that BRUKINSA will become a new treatment option for WM patients in the United States."
approval was supported by a number of clinical data: the Global Phase III ASPEN Trial (NCT03053440) assessed the safety and technology of zamubrutinib compared to Irutinib treatment WM; 2173) The safety and effectiveness of zamubrutinib therapy recurrence/refragrant WM was evaluated in China, and the safety and effectiveness of zaubrutinib in the treatment of B-cell malignancies was evaluated in the Global Phase I/II Trial (NCT02343120).
