In May 2025, the U.S. Food and Drug Administration (FDA) accepted and granted priority review for the new drug application (NDA) for the oral human epidermal growth factor receptor 2 (HER2) inhibitor Sevabertinib (Hyrnuo, BAY 2927088), which was subsequently approved on November 19, 2025. Sevabertinib is a highly selective and reversible HER2 tyrosine kinase inhibitor indicated for adult patients with HER2-mutant advanced non-small cell lung cancer (NSCLC) who have received prior systemic therapy. The launch of Sevabertinib provides a new oral targeted option for the adjuvant treatment of NSCLC. Clinical studies have demonstrated promising antitumor activity across different patient populations, with particularly high objective response rates (ORR) in patients without prior HER2-targeted therapy. The most common adverse events include diarrhea, hepatotoxicity, and interstitial lung disease, which are generally manageable. This review summarizes the mechanism of action, pharmacokinetics, clinical efficacy, safety profile, and drug interactions of Sevabertinib to support its rational clinical use.