Drugs.com Clinical Trial ResultsOriginal article
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
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Summary
Cullinan Therapeutics initiated a New Drug Application submission for zipalertinib plus chemotherapy in first-line EGFR Exon 20 Insertion Mutation NSCLC, submitted under FDA's Real-Time Oncology Review Program.
Outcome Details
New Drug Application submission initiated for zipalertinib plus chemotherapy under FDA Real-Time Oncology Review Program
Importance:7/10
Sentiment:
0.70
NDA FilingOncologyNSCLCFDA Real-Time ReviewCombination Therapy
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Published by Drugs.com Clinical Trial Results on October 1, 2026 3:10 AM