FDA Grants Breakthrough Status to Izalontamab Brengitecan
August 18, 2025
First Breakthrough Therapy Designation in the U.S. for SystImmune and Bristol Myers Squibb’s Izalontamab brengitecan (Iza-bren) based on data from the BL-B01D1-101 (CN), BL-B01D1-203 (CN), and BL-B01D1-LUNG-101