Zai Lab announced that Zocilurtatug Pelitecan has received U.S. FDA FTD for the treatment of extrapulmonary Neuroendocrine carcinomas

CAR-T Digest - August 2020

Weekly Digest - May 2026

11 May 2026: Zai Lab announced that Zocilurtatug Pelitecan has received U.S. FDA FTD for the treatment of extrapulmonary Neuroendocrine carcinomas

Zai Lab has received U.S. FDA Fast Track Designation for zocilurtatug pelitecan (zoci), its DLL3-targeting ADC, for the treatment of extrapulmonary neuroendocrine carcinomas (epNECs) following progression after first-line therapy, addressing a disease area with no approved targeted treatments and very poor prognosis
The designation further strengthens momentum behind DLL3 as an emerging ADC target beyond small cell lung cancer, particularly in aggressive neuroendocrine tumors where treatment options remain extremely limited after relapse
Recent Phase 1b/2 data presented at AACR 2026 showed encouraging activity in heavily pretreated epNEC patients, with zoci achieving a 38.2% objective response rate alongside a manageable safety profile, supporting its potential as a first-in-class therapy in the setting
Zai Lab is now actively engaging with regulators on a registrational strategy for epNECs while simultaneously advancing broader development plans for zoci across multiple DLL3-positive cancers, including second-line and first-line small cell lung cancer
With a second FDA Fast Track Designation now secured, zoci is rapidly emerging as one of the more closely watched next-generation DLL3 ADC programs, with Zai Lab positioning the asset as a potential backbone therapy for future combination approaches in neuroendocrine malignancies