Posted by Michael Wonder on 20 Aug 2025
Izalontamab brengitecan (EGFRxHER3 ADC) granted breakthrough therapy designation by US FDA for patients with previously treated advanced EGFR mutated non-small cell lung cancer
18 August 2025 - First breakthrough therapy designation in the US for SystImmune and Bristol Myers Squibb’s izalontamab brengitecan based on data from the BL-B01D1-101 (CN), BL-B01D1-203 (CN), and BL-B01D1-LUNG-101 (US/EU) studies.
SystImmune and BMS today announced that the US FDA has granted breakthrough therapy designation to izalontamab brengitecan for the treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor and platinum-based chemotherapy.
