U.S. FDA grants Orphan Drug Designation to Zai Lab’s DLL3-targeting ADC Zocilurtatug pelitecan for the treatment of Neuroendocrine Carcinomas

CAR-T Digest - August 2020

Weekly Digest - August 2026

03 August 2026: U.S. FDA grants Orphan Drug Designation to Zai Lab’s DLL3-targeting ADC Zocilurtatug pelitecan for the treatment of Neuroendocrine Carcinomas

Zai Lab’s DLL3-targeting ADC Zocilurtatug pelitecan has received Orphan Drug Designation from the U.S. FDA for the treatment of neuroendocrine carcinomas, reinforcing its potential as a first-in-class DLL3-directed ADC for this broad tumor population
The designation addresses a significant unmet need in NECs, which are aggressive malignancies frequently expressing DLL3 and have no approved targeted therapies or standard of care for previously treated patients
Zoci has already received multiple regulatory designations, including FDA FTD for extrapulmonary NECs and both FTD and ODD for small cell lung cancer, while the EMA has granted ODD for pulmonary NECs
Zoci targets DLL3, which is overexpressed across neuroendocrine malignancies including SCLC and extrapulmonary NECs and is generally associated with poor outcomes; the program is being advanced toward three registration-enabling studies in second-/third-line SCLC, first-line SCLC and extrapulmonary NECs by the end of 2026
Strategically, the U.S. ODD further strengthens Zai Lab’s positioning in the emerging DLL3 ADC landscape and supports zoci’s potential as a backbone DLL3-targeting ADC for future first-line combination regimens, including combinations with checkpoint inhibitors and T-cell engagers