Cullinan Therapeutics Starts FDA NDA for Zipalertinib Combo
Cullinan Therapeutics has initiated a New Drug Application via the FDA Real-Time Oncology Review program for zipalertinib plus platinum chemotherapy in first-line EGFR exon 20 insertion NSCLC. This submission is based on Phase 3 REZILIENT3 trial data, which met its primary endpoint. The company anticipates completing the NDA by the end of 2026.
Cullinan Therapeutics said it has initiated a New Drug Application through the FDA Real-Time Oncology Review program for zipalertinib plus platinum chemotherapy in first-line EGFR exon 20 insertion NSCLC, based on Phase 3 REZILIENT3 that met its primary endpoint. The company said NDA completion is expected by year-end 2026.