Taiho, Cullinan Therapeutics initiate rolling submission of NDA for zipalertinib

Taiho Oncology, Taiho Pharmaceutical, and Cullinan Therapeutics (CGEM) announced the companies have initiated the rolling submission of a New Drug Application to the U.S. Food and Drug Administration seeking accelerated approval of zipalertinib, an oral epidermal growth factor receptor tyrosine kinase inhibitor, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer 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 the first quarter of 2026 with an associated request for priority review. The NDA submission is based on the primary efficacy data from the REZILIENT1 trial, a Phase 1/2 clinical trial of zipalertinib monotherapy in patients with NSCLC harboring EGFR ex20ins mutations who have received prior therapy. 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.