CAMBRIDGE, Mass. — Zai Lab announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZL-1310, the company’s investigational Delta-like ligand 3 (DLL3)-targeted antibody-drug conjugate (ADC), for the treatment of extensive-stage small cell lung cancer (ES-SCLC).
ZL-1310 is currently being evaluated in a global Phase 1a/1b clinical trial (NCT06179069) and had previously received Orphan Drug designation from the FDA for the same indication. Zai Lab plans to initiate a pivotal study of the candidate in 2025, with hopes of pursuing an accelerated approval pathway.
“This designation highlights the urgent need for new treatment options for patients with small cell lung cancer and underscores the progress we’ve made in advancing ZL-1310,” said Dr. Rafael G. Amado, President and Head of Global Research and Development at Zai Lab. “We are on track to begin a pivotal study later this year, with the goal of achieving a potential accelerated approval in 2027.”
Fast Track designation is intended to speed the development and regulatory review of drugs that treat serious conditions and fill an unmet medical need. It allows for more frequent communication with the FDA and may provide eligibility for Accelerated Approval and Priority Review.
Zai Lab is scheduled to present updated clinical data on ZL-1310 at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The company will also hold an investor webcast to review the data and outline its development strategy for the drug.
