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# Orphan Status for Zai Lab’s Lung Cancer Drug
- URL: https://www.fdaweb.com/orphan-status-for-zai-labs-lung-cancer-drug/
- Published: 2025-01-23T12:00:00.000Z
- Updated: 2026-09-14T14:51:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158532

FDA has granted Zai Lab an orphan drug designation to ZL-1310, a potential first-in-class DLL3 antibody-drug conjugate (ADC) for treating small cell lung cancer (SCLC). The company says ZL-1310 has “demonstrated promising objective response rates and a favorable safety profile from the ongoing Phase 1 trial in patients with recurrent SCLC.”

ZL-1310 is described as a novel ADC that targets Delta-like ligand 3 (DLL3), an antigen that is overexpressed in many neuroendocrine tumors. “ZL-1310 comprises a humanized anti-DLL3 monoclonal antibody linked to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload,” the company says.

The drug is currently being evaluated in an ongoing Phase 1a/1b clinical trial as monotherapy and in combination with atezolizumab, an immune checkpoint inhibitor, for treating SCLC.