The US Food and Drug Administration granted Fast Track Designation to birelentinib (DZD8586), a first-in-class lymphocyte-specific protein tyrosine kinase/Bruton’s tyrosine kinase (LYN/BTK) dual inhibitor, intended for adult patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies, including BTK and BCL-2 inhibitors.
Birelentinib targets both BTK C481X mutations and BTK-independent BCR signaling, addressing unmet needs in resistant CLL/SLL, according to the manufacturer of the therapy, Dizal. Phase 1/2 studies presented at meetings this year, including the European Hematology Association Congress in Milan in 2025, showed an 84.2% response rate and 83.3% nine-month response duration in heavily pretreated patients, with manageable safety, Dizal reported in a press release.
“This recognition highlights birelentinib’s potential to meet urgent needs in CLL/SLL,” said the CEO of Dizal, Xiaolin Zhang, PhD.
