Zai Lab receives Orphan Drug Designation from the U.S. FDA for ZL-1310 (DLL3 ADC) for the treatment of Small Cell Lung Cancer (SCLC)

CAR-T Digest - August 2020

22 Jan 2025: Zai Lab receives Orphan Drug Designation from the U.S. FDA for ZL-1310 (DLL3 ADC) for the treatment of Small Cell Lung Cancer (SCLC)

Zai Lab’s First-in-class DLL3-targeting ADC for SCLC, granted FDA Orphan Drug Designation (ODD)
It showed promising objective response rates (74%) and safety in Phase 1a/1b trial for extensive-stage SCLC at the 2024 EORTC-NCI-AACR
It is built using TMALIN® platform which reduces toxicity and improves targeting with camptothecin payload
ZL-1310 is evaluated as monotherapy and with atezolizumab and it targets overexpressed antigen in SCLC, associated to poor outcomes, positioning it as crucial for Zai Lab’s oncology pipeline