New Drug Application Submission Completed for Zipalertinib Plus Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation Non-Small Cell Lung Cancer
Key Highlights
- ➤Taiho submits FDA NDA for zipalertinib plus chemotherapy in first-line EGFR ex20ins NSCLC
- ➤Phase 3 REZILIENT3 met its primary endpoint with significant median PFS improvement
- ➤Cullinan eligible for $100 million milestone upon first-line U.S. regulatory approval
- ➤RTOR submission enables earlier FDA review of efficacy and safety data
- ➤Zipalertinib remains investigational and has not been approved by any health authority
CAMBRIDGE, Mass., Nov. 12, 2026 (GLOBE NEWSWIRE) -- 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, today announced 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.
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.
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