Initial Treatment Options for HER2+ NSCLC Expand with New Zongertinib Approval
On February 26, 2026, the US Food and Drug Administration (FDA) announced the accelerated approval of zongertinib (Hernexeos®) as an initial treatment option for newly diagnosed patients with advanced non-small cell lung cancer (NSCLC) with mutations in the HER2 gene. This approval expands the usage of this treatment from August 2025 when it was only approved 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
