BeiGene bags EC approval for Brukinsa to treat WM
The European Commission (EC) has 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, says Chinese biotech BeiGene (HKEX), which developed the drug.
The approval is applicable to all 27 European Union (EU) member states, plus Iceland and Norway. BeiGene says it is working to make this new treatment option available to WM patients in the EU as quickly as possible.
The European approval of Brukinsa adds to those in the USA, China, Brazil and Canada. The drug, which is also cleared for the treatment of marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) in some markets, brought in total sales of $41.7 million in 2020, its first full year on the market, while third-quarter 2021 revenues came in at $65.8 million.
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