By Fineline Cube 
China-based CSPC Pharmaceutical Group Limited (HKG: 1093) announced that its EGFR-targeted antibody-drug conjugate (ADC) CPO301 (also known as SYS6010) has received a third Fast Track Designation from the U.S. Food and Drug Administration (FDA). The designation applies to the treatment of advanced or metastatic nonsquamous non-small cell lung cancer (NsqNSCLC) in patients without EGFR mutations or other actionable genomic alterations (AGA), following disease progression after platinum-based chemotherapy and anti-PD-(L)1 therapy.
Previous Fast Track Designations
Previously, CPO301 was granted Fast Track Designations in June 2023 and September 2023 for EGFR-mutant NSCLC and recurrent/metastatic squamous NSCLC with EGFR overexpression, respectively.
CPO301 Development
CPO301, a modified cetuximab-based ADC, is currently undergoing concurrent clinical trials in China and the United States. This Fast Track Designation underscores the potential of CPO301 to address significant unmet medical needs in lung cancer treatment.-Fineline Info & Tech