FDA Grants Orphan Drug Designation for Zai Lab’s ZL-1310 for SCLC

On 22 January 2025, Zai Lab announced that the US FDA has granted Orphan Drug Designation (ODD) to ZL-1310, a potential highly active first-in-class DLL3 antibody-drug conjugate, for the treatment of small cell lung cancer (SCLC).

According to Zai Lab, the regulatory designation follows promising data from the ongoing global Phase 1a/1b study in patients with previously treated extensive-stage SCLC after at least one prior platinum-based chemotherapy regimen.