Zai Lab's zocilurtatug Receives FDA Fast Track Designation

Zai Lab announced the U.S. Food and Drug Administration has granted Fast Track Designation to zocilurtatug pelitecan, the Company's potential first-in-class Delta-like ligand 3-targeting antibody-drug conjugate, for the treatment of extrapulmonary neuroendocrine carcinomas following progression after standard first-line therapy. epNECs are an aggressive malignancy affecting approximately 100,000 people worldwide, with no targeted therapies and no approved standard of care in previously treated disease. Zai Lab reported promising preliminary data from an ongoing registration-enabling multicenter, Phase 1b/2 clinical trial of zoci in patients with epNEC and other selected solid tumors at the American Association for Cancer Research Annual Meeting 2026 last month. In heavily pretreated patients enrolled in the Phase 1b/2 study, zoci demonstrated encouraging antitumor activity, including an objective response rate of 38.2%. Zoci also demonstrated a manageable safety profile-neutrophil count decrease was the only grade greater than or equal to3 treatment-related adverse event occurring in more than one patient.