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

Core Insights - The U.S. FDA has granted Breakthrough Therapy Designation (BTD) to izalontamab brengitecan (iza-bren) for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations [1][3][5] - Iza-bren is a bispecific antibody-drug conjugate targeting both EGFR and HER3, developed by SystImmune and Bristol Myers Squibb [2][7] - The BTD highlights the potential of iza-bren to address significant unmet clinical needs for patients who have progressed after existing treatments [3][5] Company Overview - SystImmune is a clinical-stage biopharmaceutical company focused on innovative cancer treatments, utilizing bi-specific and multi-specific antibodies, as well as antibody-drug conjugates [8][9] - Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering and delivering innovative medicines for serious diseases [10] Clinical Data - The FDA's decision was based on data from three ongoing clinical trials, indicating improved efficacy and manageable safety for iza-bren in patients with EGFR-mutant NSCLC [4][6] - NSCLC accounts for approximately 80% of lung cancer cases, with a significant portion of patients harboring activating EGFR mutations, highlighting the need for new therapies [6]