Zongertinib FDA Approval: A Breakthrough for HER2-Mutant NSCLC Patients
Introduction The U.S. Food and Drug Administration (FDA) granted accelerated approval to Zongertinib (brand name Hernexeos) on August 8, 2025, marking a significant milestone in lung cancer treatment. Zongertinib is approved for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors harbor HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations and …