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European Commission approval of Brukinsa for treatment of adults with Waldenström’s macroglobulinemia.

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Last updated:24th Nov 2021
Published:24th Nov 2021
BeiGene has announced that the European Commission (EC) approved Brukinsa (zanubrutinib) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy.

The approval is applicable to all 27 European Union (EU) member states, plus Iceland and Norway. BeiGene is working to make this new treatment option available to WM patients in the EU as quickly as possible.

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 advantages in safety compared to ibrutinib.

Condition: Waldenstrom's Macroglobulinemia
Type: drug

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