Zai Lab’s zocilurtatug pelitecan secures EMA orphan drug status

Zai Lab received orphan drug designation from the European Medicines Agency (EMA) for zocilurtatug pelitecan (Zoci), an investigational drug targeting DLL3 receptor for treating pulmonary neuroendocrine carcinomas. The EMA's Committee for Orphan Medicinal Products recommended this designation because early clinical trials showed more favorable effects compared to existing therapies, particularly in patients with small cell lung cancer. The US Food and Drug Administration previously granted this drug fast track and orphan drug designations. Zai Lab plans three registration-enabling studies to be completed by the end of 2026. The orphan drug designation provides benefits including potential market exclusivity after approval and reduced development fees. The drug targets DLL3, a protein commonly expressed in neuroendocrine cancers associated with poor patient outcomes.