New Drug Application Submission Initiated for Zipalertinib Plus Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA Real-Time Oncology Review Program
Globe Newswire•01/10/2026•19:30 ET
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Key Highlights
- ➤REZILIENT3 met its primary endpoint with statistically significant, clinically meaningful progression-free survival improvement
- ➤NDA submission initiated under FDA Real-Time Oncology Review for first-line EGFR exon20ins NSCLC
- ➤NDA submission completion expected by year-end 2026
- ➤Cullinan Therapeutics (CGEM) eligible for $100 million milestone upon first-line U.S. regulatory approval
- ➤Monotherapy NDA remains under FDA review with February 27, 2027 PDUFA target action date
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
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