New Accelerated Approval for HER2-positive NSCLC
On November 19, 2025, the US Food and Drug Administration (FDA) announced the accelerated approval of sevabertinib (Hyrnuo®) to treat patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) with specific mutations in the HER2 gene. This approval is for patients who have been previously treated with HER2-targeted therapies, as well as patients who have received previous treatment that did not target HER2. 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
