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

Cullinan Therapeutics announced the initiation of a New Drug Application (NDA) submission to the FDA for zipalertinib in combination with platinum-based chemotherapy for treating previously untreated EGFR exon 20 insertion NSCLC. The Phase 3 REZILIENT3 trial met its primary endpoint, demonstrating statistically significant improvement in median progression-free survival. The NDA submission is expected to be completed by year-end 2026 under the FDA's Real-Time Oncology Review program.