FDA Grants Accelerated Approval to BeiGene’s Brukinsa for Mantle Cell Lymphoma
BeiGene’s Brukinsa (zanubrutinib) received accelerated approval from the FDA for treating adults with mantle cell lymphoma that have received at least one prior therapy.
The approval was supported by a clinical trial of 86 patients who had received at least one prior treatment, with 84 percent of patients showing a positive response with a median duration of response of 19.5 months. The trial was supported by an additional trial of 32 patients, in which 84 percent had tumor shrinkage with a median duration of response of 18.5 months.
The approval marks BeiGene’s first approval in the U.S. Brukinsa previously received breakthrough therapy and orphan drug designation.