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BeiGene's Brukinsa Approved In Europe For Rare Type Of Blood Cancer

The European Commission has approved BeiGene Ltd’s (NASDAQ: BGNE) BRUKINSA (zanubrutinib) for Waldenström’s macroglobulinemia (WM).

  • WM is a type of non-Hodgkin lymphoma. This rare blood cell cancer is characterized by an excess of abnormal white blood cells in the bone marrow.
  • The approval covers adult WM patients who have received at least one prior therapy or the first-line treatment of patients unsuitable for chemo-immunotherapy.
  • The EC approval for BRUKINSA follows a positive opinion granted in September by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), based on the results of the ASPEN trial. 
  • Although the primary endpoint of statistical superiority related to deep response, very good partial response (VGPR) or better, was not met, BRUKINSA demonstrated clinical benefit with safety advantages compared to ibrutinib.
  • Related Link: BeiGene’s Brukinsa Scores FDA Approval For Marginal Zone Lymphoma.
  • Price Action: BGNE shares closed lower by 1.88% at $347.95 on Tuesday.

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