2021-11-27| Trials & Approvals

Brukinsa Receives EU Approval for the Treatment of Rare Lymphoma

by Rajaneesh K. Gopinath
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Just months after receiving FDA approval, BeiGene's Brukinsa (zanubrutinib) has garnered authorization from the European Commission for treating Waldenström’s macroglobulinemia (WM), a rare type of lymphoma.

On November 23rd, BeiGene announced that the EC has approved Brukinsa for patients with WM who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy The approval follows a positive CHMP opinion granted last September after the drug registered encouraging Phase 3 results in the ASPEN trial.

Brukinsa is a small molecule inhibitor of Bruton's tyrosine kinase (BTK) that originally bagged FDA approval for treating Mantle Cell Lymphoma in 2019. In September 2021, it received the agency's nod for a second indication, this time to treat WM. With the latest approval, Brkinsa is now okayed for WM treatment in China, Canada, the US, and 27 European Union member states, plus Iceland and Norway.

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