China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its ZL-1310, a potential first-in-class DLL3-targeted antibody drug conjugate (ADC) for the treatment of small cell lung cancer (SCLC). This designation underscores the drug’s potential to address significant unmet medical needs in this rare and aggressive form of lung cancer.
Clinical Development and Results
ZL-1310 has demonstrated a good objective response rate and safety profile in an ongoing Phase I clinical study in recurrent SCLC patients. These results highlight the potential therapeutic benefits of ZL-1310, positioning it as a promising candidate for further development in the treatment of SCLC.
Future Outlook
With the FDA’s Orphan Drug Designation, Zai Lab is poised to advance ZL-1310 through its clinical development program. This milestone supports the company’s commitment to bringing innovative treatments to patients with rare cancers, enhancing its pipeline of targeted therapies.-Fineline Info & Tech
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