Zai Lab Secures Orphan Drug Designation from FDA for ZL-1310 in Small Cell Lung Cancer Treatment
Thursday, January 23, 2025
Zai Lab has announced that the United States Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to ZL-1310, a Delta-like ligand 3 (DLL3) antibody-drug conjugate (ADC), for the treatment of small cell lung cancer (SCLC).
SCLC is an aggressive form of lung cancer, representing approximately 15% of all lung cancer cases globally. Around two-thirds of patients are diagnosed at an extensive stage, which is associated with high relapse rates and poor outcomes.
Median survival following initial therapy is about 12 months, and five-year survival rates remain below 10%. Treatment options are limited, with many patients experiencing disease progression despite current therapies, highlighting the need for innovative and effective treatments.
ZL-1310 is positioned as a potential first-in-class therapy for patients with this aggressive cancer type.
The ODD status enables ZL-1310 to benefit from specific regulatory incentives, including tax credits for clinical trials, a waiver of the Prescription Drug User Fee Act application fee, and the potential for seven years of market exclusivity in the United States following approval.
This designation follows encouraging early-stage clinical data from an ongoing Phase 1a/1b trial involving patients with previously treated extensive-stage SCLC.
Data from the trial, presented at the EORTC-NCI-AACR Symposium 2024, highlighted promising objective response rates and a favourable safety profile for ZL-1310.
ZL-1310 is part of Zai Lab's oncology pipeline and targets DLL3, a protein overexpressed in neuroendocrine tumours such as SCLC.
The therapy uses a novel ADC platform, TMALIN®, designed to address limitations associated with earlier ADC technologies, such as off-target toxicity.
The treatment incorporates a humanised monoclonal antibody linked to a camptothecin derivative, a topoisomerase 1 inhibitor, to deliver targeted therapy to tumour cells.
The ongoing Phase 1 clinical trial is assessing ZL-1310 as a standalone therapy and in combination with atezolizumab, an immune checkpoint inhibitor, for extensive-stage SCLC.
Source: zailaboratory.com
