Izalontamab brengitecan (EGFRxHER3 ADC) granted Breakthrough Therapy Designation by U.S. FDA for patients with previously treated advanced EGFR-mutated non-small cell lung cancer

CAR-T Digest - August 2020

Weekly Digest - August 2025

18 August 2025: Izalontamab brengitecan (EGFRxHER3 ADC) granted Breakthrough Therapy Designation by U.S. FDA for patients with previously treated advanced EGFR-mutated non-small cell lung cancer

The U.S. FDA granted Breakthrough Therapy Designation to Izalontamab brengitecan (iza-bren), an EGFRxHER3 bispecific ADC, for patients with advanced EGFR-mutated NSCLC who progressed after EGFR TKI and platinum-based chemotherapy
This marks the first Breakthrough Therapy Designation in the U.S. for SystImmune and Bristol Myers Squibb, based on data from three ongoing clinical trials in China, the U.S., Europe, and Japan
Iza-bren carries a topoisomerase I inhibitor payload and is designed to address resistance and limited treatment options after progression on current EGFR-targeted therapies
Clinical trials showed improved efficacy with a manageable safety profile in patients with exon 19 deletions or exon 21 L858R mutations
The designation highlights iza-bren’s potential to fill a major unmet need in EGFR-mutated NSCLC and will expedite its development and review process