Cullinan Therapeutics said Oct. 1 it has begun the new drug application process for zipalertinib plus platinum-based chemotherapy in previously untreated, locally advanced or metastatic EGFR exon 20 insertion non-small cell lung cancer.
The filing is being handled under the FDA’s real-time oncology review program, with completion of the NDA expected by year-end 2026.
The company said the submission is based on Phase 3 Rezilient3 data showing the combination met its primary endpoint and delivered the longest median progression-free survival reported to date in first-line EGFR exon 20 insertion NSCLC. Cullinan did not disclose the exact median PFS figure in the release.
Zipalertinib already has FDA breakthrough therapy designation in a different setting: for patients with locally advanced or metastatic EGFR exon 20 insertion NSCLC who have previously received platinum-based chemotherapy.
Separately, an NDA for zipalertinib monotherapy in the second-line setting remains under FDA review, with a PDUFA target date of Feb. 27, 2027.
Cullinan said it could receive $30 million upon second-line U.S. regulatory approval and $100 million upon first-line U.S. regulatory approval. Today the company's shares have moved -5.34% to a price of $14.53. For more information, read the company's full 8-K submission here.
