Cullinan Therapeutics and partners initiate NDA application for zipalertinib

Cullinan Therapeutics (CGEM) and Otsuka Holdings (OTSKF) subsidiaries Taiho Oncology and Taiho Pharmaceutical have initiated the rolling submission of a New Drug Application, or NDA, to the FDA seeking accelerated approval of zipalertinib, an oral epidermal growth factor receptor, or EGFR, tyrosine kinase inhibitor, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer, or NSCLC, with EGFR exon 20 insertion mutations who have previously received platinum-based systemic chemotherapy. Zipalertinib previously received Breakthrough Therapy Designation in 2021, which with FDA agreement, allows submission of portions of the application as they are completed. The companies anticipate completion of the NDA submission in 1Q26 with an associated request for priority review. Positive results from the REZILIENT1 trial were presented at the 2025 American Society of Clinical Oncology Annual Meeting and were simultaneously published in the Journal of Clinical Oncology.