The FDA approved Zongertinib (Hernexeos®, BI 1810631) in August 2025 for unresectable or metastatic non-squamous non-small cell lung cancer (nSCLC) harboring HER2 mutations, granting priority review based on positive Phase 1/2 data. The drug features targeted covalent inhibition sparing EGFR, offering a precision medicine approach for a historically underserved patient subgroup. This first-in-class selective HER2 inhibitor is positioned as a novel therapy option in this difficult-to-treat lung cancer subset, fulfilling an unmet clinical need with encouraging safety and efficacy data.