BeiGene's Brukinsa (zanubrutinib) has been accepted for review by regulators in Europe to treat patients with Waldenström’s macroglobulinemia (WM).
The drug has been developed for patients who have received at least one prior therapy or as first-line treatment for patients unsuitable for chemo-immunotherapy.
WM is a rare lymphoma representing around 1% of all non-Hodgkin lymphomas and typically progresses slowly after diagnosis.
In Europe, the estimated incidence of WM is approximately seven for every one million men and four for every one million women.
Brukinsa is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) being evaluated globally in a broad pivotal clinical programme as a monotherapy and in combination with other therapies to treat various B-cell malignancies.