The FDA granted accelerated approval to zanubrutinib (Brukinsa, BeiGene) capsules for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
The FDA’s approval was based on efficacy results from two single-arm clinical trials that measured how many patients experienced complete or partial shrinkage of their tumors after treatment. The trials assessed overall response rate (ORR) per 2014 Lugano classification as the primary end point.