Zai Lab (ZLAB) said Tuesday that the European Medicines Agency (EMA) has granted orphan drug designation to its experimental therapy, zocilurtatug pelitecan, for the treatment of pulmonary neuroendocrine carcinomas, a type of lung cancer.
The company said the designation follows a recommendation from the EMA's Committee for Orphan Medicinal Products, which cited preliminary clinical data suggesting that the therapy may offer a clinically meaningful advantage over currently approved treatments for relapsed or refractory extensive-stage small cell lung cancer, including the potential for durable responses.
Zai Lab said the orphan designation provides regulatory incentives that may support the therapy's development, including potential market exclusivity upon approval, reduced regulatory fees, and enhanced regulatory support.
Comments