GlobeNewswire·Nov 12, 2026, 4:30 PM ET

New Drug Application Submission Completed for Zipalertinib Plus Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation Non-Small Cell Lung Cancer

Taiho Oncology submitted a New Drug Application (NDA) to the FDA for zipalertinib combined with platinum-based chemotherapy to treat previously untreated locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.
The submission utilizes the FDA's Real-Time Oncology Review (RTOR) program to facilitate earlier data review, with a standard review period & potential PDUFA target action date to follow.
The NDA is supported by Phase 3 REZILIENT3 trial data showing statistically significant & clinically meaningful improvements in median progression-free survival versus chemotherapy alone.
Cullinan Therapeutics is eligible for milestone payments of $30 million upon second-line U.S. approval & $100 million upon first-line U.S. approval.
Zipalertinib (CLN-081/TAS6417) is an investigational, orally available, next-generation irreversible EGFR inhibitor developed by Taiho Oncology in collaboration with Cullinan Therapeutics.
EGFR exon 20 insertion mutations account for up to 4% of global NSCLC cases & approximately 12% of EGFR mutations within the U.S. NSCLC population.
Cullinan Therapeutics (Nasdaq: CGEM) focuses on developing disease-modifying T cell engagers for autoimmune diseases & cancer.