Cullinan Therapeutics, Inc. (Nasdaq: CGEM) announced on October 1, 2026, that it has initiated a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA). The filing seeks approval for zipalertinib in combination with platinum-based chemotherapy for the treatment of patients with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) that harbors epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations.
The submission is being made under the FDA’s Real-Time Oncology Review (RTOR) program. This program allows sponsors to submit clinical data in advance of the complete application to facilitate an earlier review of efficacy and safety results. Cullinan expects to complete the NDA submission by the end of 2026.
The NDA is based on data from the Phase 3 REZILIENT3 trial. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in median progression-free survival for zipalertinib plus chemotherapy compared to chemotherapy alone. These results were presented at the International Association for the Study of Lung Cancer’s 2026 World Conference on Lung Cancer.
Zipalertinib currently holds FDA Breakthrough Therapy designation for patients with locally advanced or metastatic EGFR ex20ins NSCLC who have previously received platinum-based chemotherapy. An NDA seeking accelerated approval for zipalertinib monotherapy in this indication remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027.
Cullinan is eligible to receive milestone payments from Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. These include a $30.0 million payment upon U.S. regulatory approval for the second-line treatment indication and up to a $100.0 million payment upon approval for the first-line treatment indication.
