On November 12, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, reported their partner Taiho Oncology, Inc. completed a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) 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) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations.
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The submission was made under the FDA’s Real-Time Oncology Review (RTOR) program, which allows sponsors to submit clinical data in advance of the complete application to facilitate earlier review of efficacy and safety results. The completed application will undergo the standard review period with the FDA, and, if accepted, a Prescription Drug User Fee Act (PDUFA) target action date will be assigned.
The NDA is based on the Phase 3 REZILIENT3 trial, which met its primary endpoint at an interim analysis, demonstrating a statistically significant and clinically meaningful improvement in median progression-free survival (PFS) for zipalertinib plus chemotherapy versus chemotherapy alone. These results were presented in a Presidential Symposium at the International Association for the Study of Lung Cancer’s (IASLC) 2026 World Conference on Lung Cancer (WCLC).
Cullinan Therapeutics is eligible to receive $30 million and $100 million in milestone payments upon second-line and first-line U.S. regulatory approvals, respectively.
About Zipalertinib
Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib is investigational and has not been approved by any health authority.
Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.
About EGFR Exon 20 Insertion Mutations
NSCLC is a common form of lung cancer and up to 4% of all cases globally have EGFR ex20ins.1 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations,1 with insertions at exon 20 accounting for up to 12% of these mutations.
(Press release, Cullinan Oncology, NOV 12, 2026, View Source [SID1234674717])