Officials with the FDA today granted accelerated approval to zanubrutinib (Brukinsa, BeiGene) for the treatment of mantle cell lymphoma (MCL) in adults who have received at least 1 prior therapy, according to a press release. MCL, an aggressive form of non-Hodgkin lymphoma, occurs from B-cells originating in the "mantle zone." The disease, which typically has a median survival of 3 to 4 years, is estimated to affect approximately 74,200 individuals in the United States in 2019. Zanubrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, previously received Breakthrough Therapy designation in this indication from the FDA. The accelerated approval is based on efficacy results from 2 single-arm clinical trials and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial, according to BeiGene.