NDA Submission Initiated for Zipalertinib + Chemo in 1L EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA Real-Time Oncology Review Program
Cullinan Therapeutics announced the initiation of 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 under the FDA’s Real-Time Oncology Review (RTOR) program. The RTOR program allows sponsors to submit clinical data in advance of the complete application to facilitate earlier review of efficacy and safety results. Completion of the NDA submission is expected by year-end 2026.
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