European Medicines Agency to review Marketing Authorisation Application for zanubrutinib for the treatment of Waldenström’s Macroglobulinemia (WM)

Zanubrutinib is a small molecule inhibitor of Bruton’s tyrosine kinase. Clinical data in the application include a Phase III trial comparing it to ibrutinib in patients with relapsed/refractory or treatment-naïve disease.

SPS commentary:

In November 2019, zanubrutinib received accelerated approval in the US for the treatment of mantle cell lymphoma. It is currently in Phase III development in the US and EU for the treatment of Waldenström’s macroglobulinemia.


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