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

Zipalertinib combination therapy achieved the longest median progression-free survival reported to date in first-line EGFR exon20 insertion non-small cell lung cancer in the Phase 3 REZILIENT3 trial. The result represents a potentially meaningful clinical differentiation in a difficult-to-treat NSCLC subset, although the article provides no numerical efficacy or safety data.