Cullinan initiates FDA NDA submission for zipalertinib plus chemotherapy under RTOR program
CGEM•Cullinan initiated an FDA Real-Time Oncology Review NDA submission for zipalertinib with platinum chemotherapy in first-line EGFR exon 20 insertion NSCLC, with completion expected by year-end 2026.
1. Submission and trial data
The submission is supported by Phase 3 REZILIENT3 data showing a median progression-free survival benefit versus chemotherapy alone. A separate accelerated-approval NDA for zipalertinib monotherapy in second-line disease remains under FDA review, with a Feb. 27, 2027 PDUFA date.
