Zai Lab says FDA grants Fast Track status to zoci for epNEC treatment

• Zai Lab received FDA Fast Track designation for zocilurtatug pelitecan (Zoci), a DLL3-targeting antibody-drug conjugate, in extrapulmonary neuroendocrine carcinomas that have progressed after standard first-line therapy.
• Early results were already presented at AACR Annual Meeting 2026, pointing to meaningful tumor shrinkage in heavily pretreated patients, supporting a potential first-in-class positioning in a setting with no approved options.
• Safety profile in the ongoing Phase 1b/2 study was described as manageable, with blood count suppression flagged as the main severe treatment-related risk.
• Program is moving toward a registration path, with regulatory discussions underway, raising prospects for an accelerated development timeline in this indication.
• Designation marks Zoci second Fast Track award, following a May 2025 Fast Track in extensive-stage small cell lung cancer.

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