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The FDA accepts a supplemental new drug application for zanubrutinib in Waldenström’s macroglobulinemia

Feb 18, 2021

On February 17, 2021, it was announced that the U.S Food and Drug Administration (FDA) accepted a supplemental new drug application for zanubrutinib, a small molecule Bruton’s tyrosine kinase inhibitor, for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). The decision was based on safety and efficacy data from 351 patients with WM across three trials: the phase III ASPEN study (NCT03053440), which compared zanubrutinib to ibrutinib for the treatment of WM; a phase II Chinese trial (NCT03332173) in relapsed/refractory (R/R) WM; and a phase I/II global trial (NCT02343120) in patients with B-cell malignancies. Safety data from 779 patients, across six clinical trials with zanubrutinib, were also included in the application.1

Zanubrutinib has previously received accelerated approval by the FDA for the treatment of patients with R/R mantle cell lymphoma. Zanubrutinib was also granted approval in China for R/R mantle cell lymphoma, as well as R/R chronic lymphocytic leukemia and small lymphocytic lymphoma. 1

  1. BeiGene announces U.S. FDA acceptance of supplemental new drug application for BRUKINSA (zanubrutinib) in Waldenström’s macroglobulinemia. Published Feb 17, 2021. Accessed Feb 18, 2021.