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
NDA FilingZipalertinibPositive
AI Analysis
Summary
Zipalertinib plus chemotherapy NDA submitted for first-line EGFR exon 20 insertion NSCLC under FDA Real-Time Oncology Review Program. Phase 3 REZILIENT3 study demonstrated longest median progression-free survival observed to date in this indication.
Clinical Trial Data
Phase
Phase 3
Primary Endpoint
Met
Outcome Details
New Drug Application submitted for zipalertinib plus chemotherapy under FDA Real-Time Oncology Review Program
Importance:8/10
Sentiment:
0.70
NDA filingEGFR exon 20 insertionNSCLCReal-Time Oncology ReviewPhase 3 REZILIENT3progression-free survival
Read the original article
Published by GlobeNewswire Clinical Studies on October 1, 2026 11:30 PM