Cullinan starts FDA review of zipalertinib with chemotherapy

Cullinan Therapeutics said on 1 October 2026 that it has initiated a New Drug Application submission to the U.S. Food and Drug Administration for zipalertinib in combination with platinum-based chemotherapy in previously untreated, locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. The company said the filing is being made under the FDA’s Real-Time Oncology Review programme, or RTOR, and that completion of the application is expected by year-end 2026.

For patients and clinicians following this programme, the practical point is that RTOR allows sponsors to send clinical data before the full application is complete so the agency can begin reviewing efficacy and safety results earlier. Cullinan said the application is based on Phase 3 REZILIENT3 data, which met its primary endpoint and showed a statistically significant and clinically meaningful improvement in median progression-free survival for zipalertinib plus chemotherapy versus chemotherapy alone.

The company said those results were presented at the International Association for the Study of Lung Cancer’s 2026 World Conference on Lung Cancer during a Presidential Symposium. It also said zipalertinib already has FDA Breakthrough Therapy designation for patients with locally advanced or metastatic EGFR exon 20 insertion NSCLC who have previously received platinum-based chemotherapy, and that a separate NDA for zipalertinib monotherapy in that indication remains under FDA review with a target action date of 27 February 2027.

Cullinan also said it is eligible to receive $30 million and $100 million in milestone payments upon second-line and first-line U.S. regulatory approvals, respectively. Zipalertinib, also known as CLN-081/TAS6417, is described by the company as an investigational oral small molecule designed to target activating EGFR mutations and is not approved by any health authority.