Reported Earlier, Cullinan Therapeutics Initiates NDA Submission For Zipalertinib Plus Chemotherapy In First-Line EGFR Exon 20 Insertion NSCLC Under FDA RTOR Program After Phase 3 REZILIENT3 Trial Met Primary Endpoint

In the Phase 3 REZILIENT3 study, zipalertinib combination therapy demonstrated longest median progression-free survival observed to date in first-line EGFR exon20ins NSCLC 

After agreement with the U.S. FDA, Real-Time Oncology Review program submission process initiated; completion of NDA submission expected by year-end 2026