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A Phase 2, Single-Arm, Open-Label, Multicenter Study of Bruton's Tyrosine Kinase (BTK) Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM)

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Trial Profile

A Phase 2, Single-Arm, Open-Label, Multicenter Study of Bruton's Tyrosine Kinase (BTK) Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 11 Mar 2022

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At a glance

  • Drugs Zanubrutinib (Primary)
  • Indications Waldenstrom's macroglobulinaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors BeiGene
  • Most Recent Events

    • 12 Jul 2021 Results published in the Clinical Cancer Research
    • 18 Jun 2021 According to a BeiGene media release, BRUKINSA (zanubrutinib) has received conditional approval from the China National Medical Products Administration (NMPA) for the treatment of adult patients with Waldenstrom's macroglobulinemia (WM) who have received at least one prior therapy, based on data from this trial.
    • 17 Feb 2021 According to a BeiGene media release, The Prescription Drug User Fee Act (PDUFA) target action date is October 18, 2021.
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