The US Food and Drug Administration (FDA) on Thursday awarded accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy, through its breakthrough therapy designation & orphan drug designation.

This approval was granted to BeiGene USA Inc.

Mantle cell lymphoma is a type of non-Hodgkin's lymphoma representing 3-10% of all non-Hodgkin's lymphomas in the US. By the time it is diagnosed, mantle cell lymphoma has usually spread to the lymph nodes, bone marrow as well as other organs.

A single-arm clinical trial of Brukinsa included 86 patients with mantle cell lymphoma with at least one prior treatment. The trial measured the overall response rate of how many patients experienced complete or partial shrinkage of their tumours after treatment.

In the trial, 84% of patients had tumour shrinkage with a median duration of response (time between the initial response to therapy and subsequent disease progression or relapse) of 19.5 months. This trial was supported by an additional single-arm trial that included 32 patients, in which 84% of patients had tumour shrinkage with a median duration of response of 18.5 months.