FDA accepts for review the sNDA for the 1st-line treatment of non-small cell lung cancer with EGFR exon 20 insertion mutations – AstraZeneca

A supplemental New Drug Application for approval of Zegfrovy (sunvozertinib)  in the 1st-line setting has been accepted by the FDA, supported by positive results from the global WU-KONG28 Phase III trial of Zegfrovy in 1st-line NSCLC with EGFR exon 20 insertion mutations.
These data were presented at the 2026 American Society of Clinical Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine. Zegfrovy has also been submitted for approval in the 1st-line setting to China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE both granted Breakthrough Therapy Designation to Zegfrovy in this setting.

Zegfrovy is approved in the US and China for the 2nd-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. Patients with NSCLC with EGFR exon 20 insertion mutations experience a real-world five-year overall survival rate as low as 8% underscoring the unmet need for new treatment options. Zegfrovy is already available to patients in China in the 2nd-line setting and AstraZeneca will launch in the US during the fourth quarter of 2026 for this indication.

Citation: First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations. Authors: Caicun Zhou, M.D., Ph.D., Laurent Greillier, M.D., Ph.D., Geoffrey Liu, M.D. et al. Published May 29, 2026 N Engl J Med 2026;395:765-775 DOI: 10.1056/NEJMoa2604461 VOL. 395 NO. 8