Sevabertinib: First Approval

Sevabertinib (HYRNUO^®), an oral, reversible, small molecule tyrosine kinase inhibitor (TKI) of human epidermal growth factor receptor 2 (HER2) that also shows activity against epidermal growth factor receptor (EGFR), is being developed by Bayer for the treatment of solid tumours with mutations in HER2 or EGFR genes. Sevabertinib is derived from Bayer's strategic research alliance with the Broad Institute of MIT and Harvard. In November 2025, sevabertinib was approved under accelerated approval in the USA for use in adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumours have HER2 (ERBB2) TK domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This article summarizes the milestones in the development of sevabertinib leading to this first approval for the treatment of locally advanced or metastatic NSCLC with HER2 (ERBB2) activating mutations.