HERNEXEOS® (Zongertinib)

The FDA on August 8, 2025, granted accelerated approval to HERNEXEOS®, a kinase inhibitor, for adults with unresectable or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. HERNEXEOS® is a product of Boehringer Ingelheim Pharmaceuticals, Inc.