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Home›business›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
business

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

By Info60 UK Desk•Summary of reporting by Investing News Network (inn)•16h ago•0 views•
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
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 submissio...
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