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Businesswire 2023 — BeiGene Receives New Approvals for BRUKINSA (zanubrutinib) in China
“BeiGene…announced the China National Medical Products Administration (NMPA) approved four applications for BRUKINSA (zanubrutinib), the company’s Bruton’s tyrosine kinase inhibitor (BTKi), including two Supplemental New Drug Applications for treatment-naïve adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and Waldenström’s macroglobulinemia (WM), and two Supplemental Applications for conversions from conditional approval to regular approval….NMPA converted these conditional approvals to regular approvals for R/R CLL/SLL and R/R WM in April 2023….The new approvals of BRUKINSA for CLL/SLL are supported by data from SEQUOIA…in patients with previously untreated CLL/SLL. The new approvals of BRUKINSA for WM are based on data from ASPEN…the first and only global Phase 3 head-to-head clinical trial of BTK inhibitors in WM.”
SIE 2022 (Poster) — ASPEN: LONG-TERM FOLLOW-UP RESULTS OF A PHASE 3 RANDOMIZED STUDY OF ZANUBRUTINIB (ZANU) VERSUS IBRUTINIB (IBR) IN PATIENTS AFFECTED / AND WALDENSTRÖM (WM) MACROGLOBULINEMIA
SOHO 2022 (Poster) — ASPEN: Long-Term Follow-Up Results of a Phase 3 Randomized Trial of Zanubrutinib vs Ibrutinib in Patients With Waldenström Macroglobulinemia
PPLC 2022 (Poster) — ASPEN: Long-Term Follow-up Results of a Phase 3 Randomized Trial of Zanubrutinib (ZANU) vs Ibrutinib (IBR) in Patients (PTS) with Waldenström Macroglobulinemia (WM)
EHA 2022 (On-demand, Poster) — ASPEN: LONG-TERM FOLLOW-UP RESULTS OF A PHASE 3 RANDOMIZED TRIAL OF ZANUBRUTINIB (ZANU) VS IBRUTINIB (IBR) IN PATIENTS (PTS) WITH WALDENSTRÖM MACROGLOBULINEMIA (WM)
ASCO 2022 (On-demand, Poster) — ASPEN: Long-term follow-up results of a phase 3 randomized trial of zanubrutinib (ZANU) versus ibrutinib (IBR) in patients with Waldenström macroglobulinemia (WM).
Businesswire 2021 — BeiGene Announces Authorisation of BRUKINSA (zanubrutinib) from the United Kingdom’s MHRA for the Treatment of Adults with Waldenström’s Macroglobulinemia in Great Britain.