The FDA granted accelerated approval to zanubrutinib (Brukinsa, BeiGene) for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20–based regimen.
The approval is based on two open-label, multicenter, single-arm trials: the pivotal phase 2 MAGNOLIA (BGB-3111-214) trial (ClinicalTrials.gov Identifier: NCT03846427) and the phase 1/2 BGB-3111-AU-003 trial (ClinicalTrials.gov Identifier: NCT02343120). In both trials, zanubrutinib was