Zai Lab Ltd. has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZL-1310, a potential first-in-class Delta-like ligand (DLL3) antibody-drug conjugate $(ADC)$, for the treatment of extensive-stage small cell lung cancer (ES-SCLC). This designation is a significant milestone, highlighting the need for new treatment options in this area and facilitating the expedited development and review of ZL-1310. The company is set to initiate a pivotal study for the drug in 2025, with the aim of achieving accelerated approval by 2027. ZL-1310 is currently being evaluated in a global Phase 1a/1b clinical trial and has previously received an Orphan Drug designation for SCLC from the FDA.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Zai Lab Ltd. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250519241527) on May 19, 2025, and is solely responsible for the information contained therein.