Zai Lab recently announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to zocilurtatug pelitecan (zoci, formerly ZL-1310), the company’s potential first-in-class Delta-Like Ligand 3 (DLL3)-targeting Antibody Drug Conjugate (ADC), for the treatment of pulmonary neuroendocrine carcinomas (NECs).

The designation follows a positive opinion from the EMA’s Committee for Orphan Medicinal Products (COMP), recognising both the seriousness of neuroendocrine carcinomas and the need for new treatment options. SCLC is the most significant pulmonary NEC, accounting for around 15 percent of the approximately 2.5 million patients diagnosed with lung cancer worldwide each year (an estimated 375,000 new cases annually), and is one of the most aggressive and lethal solid tumors.

In granting the designation, the COMP noted that preliminary clinical data in patients with relapsed or refractory extensive-stage SCLC suggest zoci may offer a more favorable effect than currently authorised therapies, including durable responses, a finding the committee characterised as a clinically relevant advantage.

The US Food and Drug Administration (FDA) previously granted Fast Track Designation (FTD) and ODD to zoci for SCLC. The FDA also recently granted FTD to zoci for extrapulmonary NECs (epNECs).

Rafael G. Amado, MD, President, Head of Global Research and Development, Zai Lab, said, “This important designation from the EMA supports zoci’s potential to become a first-in-class therapy for pulmonary neuroendocrine carcinomas. This milestone is another demonstration of Zai Lab’s commitment to address critical unmet needs for patients with limited treatment options.”

The EMA’s ODD provides important regulatory and development incentives, including potential market exclusivity following approval, reduced development fees, and enhanced development efficiency, which may help streamline clinical development.