Cullinan starts FDA NDA submission for zipalertinib combo in 1L EGFR ex20ins NSCLC under RTOR

Cullinan Therapeutics, Inc.

NDA submission initiated for zipalertinib plus platinum-based chemotherapy in previously untreated, locally advanced or metastatic EGFR exon 20 insertion NSCLC.
Submission is under the FDA's Real-Time Oncology Review program; completion of the NDA submission expected by year-end 2026.
Based on Phase 3 REZILIENT3, which met its primary endpoint with a statistically significant improvement in median PFS vs chemotherapy alone; data presented at IASLC 2026 WCLC Presidential Symposium.
A separate NDA seeking accelerated approval for zipalertinib monotherapy in second-line EGFR ex20ins NSCLC remains under FDA review, with a PDUFA target action date of February 27, 2027.
Cullinan is eligible for $30.0 million and up to $100.0 million in Taiho milestone payments upon U.S. second-line and first-line approvals, respectively.

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