Zai Lab Granted Orphan Drug Status by U.S. FDA for ZL-1310 (DLL3 ADC) in Treating Small Cell Lung Cancer (SCLC)
Thursday, January 23, 2025
Zai Lab Limited announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ZL-1310, a novel and potentially first-in-class DLL3 antibody-drug conjugate (ADC), for treating small cell lung cancer (SCLC).
This designation acknowledges the potential of ZL-1310 to address the urgent need for innovative treatments for SCLC, especially those that offer improved efficacy and safety while being accessible in both tertiary care and community settings.
ZL-1310 has shown encouraging results in an ongoing Phase 1 trial involving patients with recurrent SCLC, demonstrating promising objective response rates and a favourable safety profile. The clinical development of ZL-1310 will continue to explore its potential across various lines of therapy in SCLC and other DLL3-expressing tumours.
With the Orphan Drug Designation, ZL-1310 becomes eligible for development benefits such as a waiver of the Prescription Drug User Fee Act application fee, tax credits for specific clinical trials, and the possibility of receiving seven years of U.S. market exclusivity upon regulatory approval.
The designation follows promising data from a global Phase 1a/1b study involving patients with previously treated extensive-stage SCLC (ES-SCLC) who had undergone at least one prior platinum-based chemotherapy regimen. These findings were presented at the EORTC-NCI-AACR (ENA) Symposium in October 2024.
ZL-1310 is part of Zai Lab’s expanding global oncology pipeline. It targets Delta-like ligand 3 (DLL3), a tumour antigen associated with poor clinical outcomes and overexpressed in various neuroendocrine cancers. ZL-1310 uses a humanised anti-DLL3 monoclonal antibody linked to a camptothecin derivative, a topoisomerase 1 inhibitor, as its payload. Developed using the TMALIN® platform, this ADC is designed to address limitations of earlier ADC therapies, such as off-target toxicity.
The ongoing Phase 1a/1b trial is investigating ZL-1310 as a monotherapy and in combination with atezolizumab, an immune checkpoint inhibitor, for treating ES-SCLC.
Source: businesswire.com
