News
BeiGene announces FDA acceptance of supplemental NDA for Brukinsa for Waldenström’s Macroglobulinemia.
BeiGene, Ltd. has announced that the FDA has accepted a supplemental new drug application (sNDA) for Brukinsa (zanubrutinib) for the treatment of adult patients with Waldenström’s Macroglobulinemia (WM). The Prescription Drug User Fee Act (PDUFA) target action date is October 18, 2021.
The sNDA package, which includes data from 351 patients with WM, was primarily based on safety and efficacy data from the global Phase III ASPEN trial of zanubrutinib compared to ibrutinib for the treatment of WM (NCT03053440), with supportive data from the pivotal Phase II trial of zanubrutinib in relapsed/refractory WM conducted in China (NCT03332173) and the global Phase 1/2 trial in patients with B-cell malignancies (NCT02343120). In addition, safety data from 779 patients in six clinical trials of Brukinsa were included in the submission.
Condition: Waldenstrom's Macroglobulinemia
Type: drug
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