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
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 (U.S.,/EU) studies REDMOND, Wash. and PRINCETON, N.J., Aug. 18, 2025...
Related Questions
How will the Breakthrough Therapy Designation for Izalontamab brengitecan affect Bristol Myers Squibb's upcoming earnings and stock valuation?
What are the potential market share gains versus existing EGFR‑targeted therapies and other ADC competitors in the advanced NSCLC space?
What regulatory timelines and reimbursement considerations could influence the long‑term revenue outlook for this new therapy?