BRIEF—BeiGene bags breakthrough status for zanubrutinib

Chinese biopharma BeiGene has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for its investigational Bruton’s tyrosine kinase (BTK) inhibitor, zanubrutinib, for adults with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Jane Huang, the company’s chief medical officer, said: “Zanubrutinib has been designed to maximize BTK occupancy and minimize off-target effects. We believe that the Breakthrough Therapy designation underscores the potential of zanubrutinib as a meaningful treatment for patients with MCL who have received at least one prior therapy.

“More than 1,300 patients worldwide have been treated with zanubrutinib, and it’s being developed in a broad clinical program that currently includes seven Phase III or pivotal trials conducted globally or in China.”