The FDA has granted accelerated approvals to two new targeted therapies for non-small cell lung cancer driven by HER2 tyrosine kinase domain mutations. Zongertinib (Hernexeos) received approval in August 2025 for patients after prior therapy, then again in February 2026 as a broader first-line-eligible option for unresectable or metastatic non-squamous NSCLC. Sevabertinib (Hyrnuo) earned its approval in November 2025 for locally advanced or metastatic non-squamous NSCLC with HER2 TKD mutations following prior systemic therapy. Both drugs target a specific molecular subgroup of lung cancer patients identified through FDA-authorized companion diagnostic testing. These approvals reflect the ongoing shift toward precision oncology, offering new hope for patients whose tumors harbor HER2 mutations — a population that previously had limited targeted options.
