Brukinsa moves forward in Europe in new indication

18 June 2020

The marketing authorization application (MAA) for Brukinsa (zanubrutinib) to treat Waldenström’s macroglobulinemia (WM) patients who have received at least one prior therapy or as first-line treatment for those unsuitable for chemo-immunotherapy has been validated for regulatory review by the European Medicines Agency (EMA).

Chinese biotech BeiGene (Nasdaq: BGNE) included in its MAA data from the Phase III ASPEN comparison of its drug versus ibrutinib, a product marketed as Imbruvica by the Johnson & Johnson (NYSE: JNJ) unit Janssen.

"We are hopeful that Brukinsa’s cardiovascular safety advantages over ibrutinib may help it become a preferred treatment option"Shares in BeiGene had risen by more than 1% after two hours of trading on Thursday.

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