Zanubrutinib granted speedy approval for mantle cell lymphomaJanuary 6, 2020
Accelerated approval has been granted to zanubrutinib (Brukinsa) capsules for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.
A single-arm clinical trial of Brukinsa included 86 patients with mantle cell lymphoma who had received at least one prior treatment. The trial measured how many patients experienced complete or partial shrinkage of their tumours after treatment (overall response rate).
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.