First Oral Targeted Therapy Approved for Advanced HER2+ NSCLC
On August 8, 2025, the US Food and Drug Administration (FDA) announced the accelerated approval of zongertinib (Hernexeos®) to treat patients with unresectable or metastatic non-small cell lung cancer (NSCLC) with mutations in the HER2 gene. This approval is for patients who have been previously treated with a systemic therapy (such as chemotherapy). Mutations in the HER2 gene (also called the ERBB2 gene) are responsible for approximately 2-3% of nonsquamous NSCLCs. These mutations activate the HER2 protein and drive cancer growth. Zongertinib is a type of targeted therapy that is given as a