CAMBRIDGE, Mass. — Zai Lab Limited said the U.S. Food and Drug Administration has granted Fast Track designation to zocilurtatug pelitecan, an antibody-drug conjugate being developed for extrapulmonary neuroendocrine carcinomas.
Zocilurtatug pelitecan, also known as zoci and formerly ZL-1310, targets Delta-like ligand 3, or DLL3. The FDA designation covers treatment of extrapulmonary neuroendocrine carcinomas following progression after standard first-line therapy.
Extrapulmonary neuroendocrine carcinomas are aggressive cancers with poor prognosis, no targeted therapies and no approved standard of care in previously treated disease, according to the company. Zai Lab said the disease affects about 100,000 people worldwide.
“This is the second FDA Fast Track Designation for zoci, underscoring the significant potential of this investigational medication to provide an important new treatment option for patients with difficult-to-treat cancers that have few available therapies,” said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. “This designation will support our efforts to advance this novel therapy through clinical development with both the speed and quality that define our approach. We are actively engaging with health authorities on a registrational plan for epNECs.”
Zai Lab recently reported preliminary data from an ongoing registration-enabling multicenter Phase 1b/2 clinical trial of zoci in patients with extrapulmonary neuroendocrine carcinoma and other selected solid tumors. The data were presented at the American Association for Cancer Research Annual Meeting 2026.
In heavily pretreated patients in the study, zoci demonstrated an objective response rate of 38.2%, according to the company. Zai Lab said the treatment also showed a manageable safety profile, with decreased neutrophil count the only grade 3 or higher treatment-related adverse event occurring in more than one patient.
The FDA previously granted Fast Track designation to zoci in May 2025 for the treatment of extensive-stage small cell lung cancer.
Fast Track designation is intended to support the expedited development and review of new drugs that address unmet medical needs or treat serious or life-threatening diseases. The designation can allow more frequent communication with the FDA and potential eligibility for Accelerated Approval and Priority Review if applicable criteria are met.
Zoci targets DLL3, a therapeutic target in small cell lung cancer that is overexpressed in many neuroendocrine carcinomas and is generally associated with poor clinical outcomes.
Zai Lab said zoci could become its first global oncology launch. The company plans three registration-enabling studies by the end of 2026 across second-line small cell lung cancer, first-line small cell lung cancer and extrapulmonary neuroendocrine carcinoma.
