Product information and disease descriptionPlace of product in therapyApproaches to treatment
Place in treatment, anticipated use, and care setting
2 evidence topics · 6 sources
Summary
The U.S. development setting is ivonescimab plus chemotherapy after progression on a third-generation EGFR TKI in EGFR-mutated nonsquamous NSCLC. Treatment in HARMONi was intravenous every 3 weeks. Summit reports a November 14, 2026 FDA action date and estimates that more than 14,000 U.S. patients could be eligible annually. That estimate describes a potential treatment population, not the incidence of EGFR-mutated NSCLC.
Ivonescimab has been authorized in China since May 2024. Akeso reports a Class I CSCO recommendation for ivonescimab plus chemotherapy after EGFR-TKI resistance. In the United States and Canada, Summit describes exceptional single-patient expanded access rather than routine commercial access.