Cullinan Therapeutics and Partners Begin FDA Rolling Submission for Zipalertinib in EGFR-Mutant NSCLC
Cullinan Therapeutics Inc., in collaboration with Taiho Oncology and Taiho Pharmaceutical, has started a rolling submission of a New Drug Application (NDA) to the FDA for zipalertinib. The drug targets EGFR-mutant NSCLC and seeks accelerated approval based on positive Phase 1/2 trial results. The submission is expected to be completed in Q1 2026, including a request for priority review.
Cullinan Therapeutics Inc., in collaboration with Taiho Oncology and Taiho Pharmaceutical, has initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zipalertinib. The submission seeks accelerated approval for zipalertinib, an oral EGFR tyrosine kinase inhibitor, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations who have previously received platinum-based chemotherapy. The NDA is supported by positive results from the REZILIENT1 Phase 1⁄2 trial and is expected to be completed in the first quarter of 2026, including a request for priority review. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cullinan Therapeutics Inc. published the original content used to generate this news brief on November 20, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT) Original Document: here
