迪哲医药：在研产品DZD8586获美国FDA快速通道认定

Core Viewpoint - DZD8586, developed by DIZHE Pharmaceutical, has received Fast Track Designation from the FDA for the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in patients who have undergone at least two lines of treatment, including BTK inhibitors and BCL-2 inhibitors [1][2]. Group 1: Product Overview - DZD8586 is a first-in-class dual-target inhibitor that simultaneously blocks both BTK-dependent and independent BCR signaling pathways, addressing resistance mutations and demonstrating high selectivity for other members of the TEC family [2]. - The drug has shown an objective response rate (ORR) of 84.2% in patients previously treated with various therapies, with a projected duration of response (DOR) rate of 83.3% over nine months [2]. Group 2: Clinical Research and FDA Designation - The Fast Track Designation was granted based on a summary analysis of Phase I/II clinical studies, with results to be presented at major oncology conferences in 2025 [2]. - Fast Track Designation allows for expedited drug development and review processes, aimed at addressing serious diseases and unmet medical needs [3].