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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