FDA grants Orphan Drug Designation
FDA grants Orphan Drug Designation status to Zai Lab’s lung cancer treatment
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Zai Lab’s delta-like ligand 3 (DLL3) antibody-drug conjugate (ADC), ZL-1310, for small cell lung cancer (SCLC).
ZL-1310 is being assessed both as a single agent and in conjunction with atezolizumab for treating ES-SCLC. SCLC represents almost 15% of the 2.5 million annual lung cancer diagnoses globally.
The designation provides the therapy with incentives such as fee waivers and tax credits to support its development, along with the possibility of seven years of market exclusivity upon approval.
Zai Lab global research and development head and president Rafael Amado stated: “Receiving an orphan drug designation for ZL-1310 recognises its potential to treat patients with SCLC. These patients have an urgent need for innovative treatment options with improved efficacy, safety and ready access in tertiary care and community settings.
“ZL-1310 has demonstrated promising objective response rates and a favourable safety profile from the ongoing Phase I trial in patients with recurrent SCLC recently disclosed. We look forward to continuing to advance the clinical development of this promising asset across lines of therapy in SCLC and other DLL3-expressing tumours.”
The designation is granted based on promising data from the ongoing Phase Ia/Ib global trial of ZL-1310 in patients with extensive-stage SCLC (ES-SCLC) who have previously undergone a minimum of one platinum-based chemotherapy regimen.
It is being assessed both as a single agent and in conjunction with the immune checkpoint inhibitor atezolizumab for treating ES-SCLC.
In May 2025, in association with Innoviva Specialty Therapeutics, the company announced its new drug application (NDA) approval by China’s National Medical Products Administration (NMPA) for XACDURO (sulbactam-durlobactam) to treat hospital-acquired and ventilator-associated bacterial pneumonia.
