Zai Lab Ltd. has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZL-1310, a potential first-in-class Delta-like ligand (DLL3) antibody-drug conjugate $(ADC)$, for the treatment of extensive-stage small cell lung cancer (ES-SCLC). This designation is a significant milestone, highlighting the need for new treatment options in this area and facilitating the expedited development and review of ZL-1310. The company is set to initiate a pivotal study for the drug in 2025, with the aim of achieving accelerated approval by 2027. ZL-1310 is currently being evaluated in a global Phase 1a/1b clinical trial and has previously received an Orphan Drug designation for SCLC from the FDA.
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