Cullinan initiates FDA NDA submission for zipalertinib plus chemotherapy under RTOR program

• Cullinan initiated an FDA Real-Time Oncology Review NDA submission for zipalertinib with platinum chemotherapy in first-line EGFR exon 20 insertion NSCLC.
• Completion of the submission is expected by year-end 2026.
• Filing 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.

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