By Fineline Cube 
China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that it has received Fast Track designation from the US Food and Drug Administration (FDA) for its ZL-1310, a potential first-in-class DLL3-targeted antibody drug conjugate (ADC). The designation is for the treatment of extensive-stage small cell lung cancer (ES-SCLC).
Previous Recognition and Current Studies
ZL-1310 was previously awarded Orphan Drug Designation (ODD) for the treatment of SCLC in the US earlier this year. The drug is currently being investigated in an ongoing global Phase Ia/Ib study (NCT06179069). Zai Lab plans to initiate a pivotal study for ZL-1310 in SCLC within this year.
Upcoming Data Presentation
The latest data from the ZL-1310 study will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. This presentation will provide further insights into the drug’s potential as a novel treatment option for patients with extensive-stage small cell lung cancer.-Fineline Info & Tech