Reported Earlier, Cullinan Therapeutics Initiates NDA Submission For Zipalertinib Plus Chemotherapy In First-Line EGFR Exon 20 Insertion NSCLC Under FDA RTOR Program After Phase 3 REZILIENT3 Trial Met Primary Endpoint

Cullinan Therapeutics has initiated the New Drug Application (NDA) submission for zipalertinib in combination with chemotherapy for first-line EGFR exon 20 insertion non-small cell lung cancer (NSCLC) under the FDA's Real-Time Oncology Review (RTOR) program. This follows the Phase 3 REZILIENT3 trial, which achieved the longest median progression-free survival reported to date for this indication. The completion of the NDA submission is anticipated by the end of 2026.