Posted by Michael Wonder on 06 Aug 2025
The US FDA granted fast track designation to Dizal's birelentinib for relapsed/refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma
6 August 2025 - Supporting data from a pooled analysis of Phase I/II studies of birelentinib showed an objective response rate of 84.2% in heavily pretreated CLL/SLL patients.
Dizal announced that the US FDA has granted fast track designation to its birelentinib (DZD8586) for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
