Zanubrutinib: First Approval.

Zanubrutinib (Brukinsa®), an orally-administered Bruton tyrosine kinase (BTK) inhibitor, is being developed by BeiGene for the treatment of B-cell malignancies. Zanubrutinib received accelerated approval in the USA on 14 November 2019 for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, based on overall response rate (ORR) seen in phase II and I/II clinical trials. This article summarizes the milestones in the development of zanubrutinib leading to this first approval for the treatment of MCL. [ABSTRACT FROM AUTHOR]