HERNEXEOS® (Zongertinib)

The FDA on February 26, 2026, granted accelerated approval to HERNEXEOS®, a kinase inhibitor, for an expanded indication 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-authorized test. HERNEXEOS® is a product of Boehringer Ingelheim Pharmaceuticals, Inc.