By Fineline Cube 
Dizal (Jiangsu) Pharmaceutical Co., Ltd (SHA: 688192) announced that its investigational product DZD8586 has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in patients who have received at least two prior lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.
Innovative Mechanism
DZD8586 is a first-in-class LYN/BTK dual-target inhibitor. It simultaneously blocks BTK-dependent and BTK-independent B-cell receptor (BCR) signaling pathways, suppresses resistance mutations to degraders, and exhibits high selectivity for other members of the TEC family. Additionally, it fully penetrates the blood-brain barrier.
Clinical Trial Results
Clinical trials demonstrated that DZD8586, at the recommended Phase 3 dose (RP3D) of 50 mg once daily (QD), achieved an objective response rate (ORR) of 84.2% in heavily pretreated CLL/SLL patients. The drug also showed a favorable safety profile.-Fineline Info & Tech