Zai Lab’s Zocilurtatug pelitecan receives EMA Orphan Drug Designation for pulmonary Neuroendocrine carcinoma

CAR-T Digest - August 2020

Weekly Digest - June 2026

16 June 2026: Zai Lab’s Zocilurtatug pelitecan receives EMA Orphan Drug Designation for pulmonary Neuroendocrine carcinoma

Zai Lab has received Orphan Drug Designation from the European Medicines Agency for Zocilurtatug pelitecan for the treatment of pulmonary Neuroendocrine carcinomas, providing important regulatory recognition for its potential first-in-class DLL3-targeting antibody-drug conjugate
The designation was supported by preliminary clinical data in patients with relapsed or refractory extensive-stage SCLC, where Zoci demonstrated durable responses and a potentially favorable clinical benefit compared with currently authorized therapies, leading the EMA’s Committee for Orphan Medicinal Products to recognize a clinically relevant advantage
Pulmonary NECs, including SCLC, represent a significant area of unmet need with limited treatment options, and the EMA designation follows recent U.S. FDA Fast Track and Orphan Drug designations for Zoci, further supporting the program’s global regulatory momentum
Zoci is a DLL3-targeting ADC designed to selectively deliver a topoisomerase I inhibitor payload to neuroendocrine tumor cells, with ongoing development across SCLC and extrapulmonary neuroendocrine carcinomas, where DLL3 is highly expressed and associated with poor clinical outcomes
Strategically, the EMA Orphan Drug Designation strengthens Zai Lab’s position in the emerging DLL3-targeted treatment landscape, supports the advancement of what could become the first globally developed ADC from Zai Lab, and reinforces the growing competitive momentum around DLL3-directed therapies in neuroendocrine cancers