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
Benzinga Newsdesk 1 month ago
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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
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