FDA grants fast track status to Zai Lab’s lung cancer treatment

This ADC, which is currently under assessment in a global Phase Ia/IIb trial, has secured orphan drug designation from the agency for SCLC.

According to the company, SCLC represents one of the most lethal solid tumours, making up about 15% of the 2.5 million patients diagnosed with lung cancer globally each year.

Notably, two-thirds of all SCLC individuals are said to be diagnosed at an extensive stage.

Zai Lab noted that DLL3 is overexpressed in several neuroendocrine tumours, including SCLC, and is typically linked to poor clinical results.

The ADC ZL-1310 consists of a humanised anti-DLL3 monoclonal antibody connected through a cleavable linker to a camptothecin derivative as its payload.

Its design incorporates an ADC technology platform known as TMALIN, which utilises the tumour microenvironment, thereby addressing the limitations of first-generation ADC therapies.

Zai Lab Global Research and Development head and president Rafael Amado said: “The FDA’s decision to grant fast track designation to ZL-1310 highlights the significant need for expanded treatment options for patients with SCLC and represents an important step in our efforts to advance a novel therapeutic option as quickly as possible.

“This designation reinforces the clinical progress we have achieved for ZL-1310 to-date, and we remain on track to initiate a pivotal study in small cell lung cancer later this year, positioning us for a potential accelerated approval in 2027.”

The fast track designation aims to accelerate the new drug development and review that fills an unmet medical need or treats life-threatening conditions.

The advantages of this status include frequent communication with the agency regarding the clinical development plan of the drug and its potential for expedited approval and priority review on meeting certain criteria.