Cullinan initiates FDA filing for lung cancer drug zipalertinib

Cullinan Therapeutics, Inc., a Massachusetts-based biopharmaceutical company, has filed a New Drug Application with the U.S. Food and Drug Administration for zipalertinib, a promising lung cancer treatment. This application targets patients with non-small cell lung cancer (NSCLC) who have EGFR exon 20 insertion mutations and have not responded to platinum-based chemotherapy.

The submission is part of the FDA’s Real-Time Oncology Review program, allowing sponsors to share clinical data ahead of the full application. Cullinan anticipates completing the NDA by the end of 2026. The data supporting the application comes from the Phase 3 REZILIENT3 trial, which demonstrated that zipalertinib, when combined with chemotherapy, significantly improved median progression-free survival compared to chemotherapy alone.

This result was presented at the 2026 World Conference on Lung Cancer. Zipalertinib has received FDA Breakthrough Therapy designation, indicating that it addresses an unmet medical need and is expected to undergo accelerated development. Although a separate NDA for zipalertinib monotherapy is still pending review, with a target decision date of February 27, 2027, Cullinan is eligible for substantial financial incentives upon regulatory approvals.

The drug, developed jointly by Cullinan, Taiho Oncology, Inc., and Taiho Pharmaceutical Co., Ltd., represents a significant advancement in the treatment of EGFR exon 20 insertion NSCLC.