Zai Lab receives U.S. FDA fast track designation for ZL-1310, a DLL3-targeted ADC, for treatment of extensive-stage small cell Lung cancer

CAR-T Digest - August 2020

Weekly Digest - May 2025

19 May 2025: Zai Lab receives U.S. FDA fast track designation for ZL-1310, a DLL3-targeted ADC, for treatment of extensive-stage small cell Lung cancer

The FDA has granted fast track status to ZL-1310, Zai Labs DLL3 antibody-drug conjugate, for treating extensive-stage small cell lung cancer (ES-SCLC)
ZL-1310 is currently being evaluated in a global Phase 1a/1b clinical trial (NCT06179069)
ZL-1310 previously received orphan drug designation from the FDA for small cell lung cancer
Zai Lab aims to start a pivotal study for ES-SCLC later this year, with potential accelerated approval targeted for 2027
Updated clinical data for ZL-1310 will be presented at the 2025 ASCO Annual Meeting, with an investor call to discuss progress and next steps