FDA gives BeiGene green light for new Brukinsa indication

The Food and Drug Administration has given BeiGene clearance for Brukinsa (zanubrutinib) for the treatment of adult patients with Waldenström’s macroglobulinemia, or WM.

WM is a type of cancer affecting two types of B cells: lymphoplasmacytoid cells and plasma cells. Both cell types are white blood cells.

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“We are delighted by today’s FDA approval for Brukinsa in its second indication, offering a new treatment option with demonstrated efficacy and safety benefits for patients with Waldenström’s macroglobulinemia," said Jane Huang, chief medical officer, hematology at BeiGene.

Brukinsa is approved in the following indications in the United States: for the treatment of mantle cell lymphoma in adult patients who have received at least one prior therapy; and for the treatment of adult patients with WM.