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FDA Moves Hyrnuo (sevabertinib) Into First-Line Therapy for HER2-Positive NSCLC

September 10, 2026

Did you know? HER2 is a gene found in cells that are important for cell growth and survival. You may also sometimes see HER2 referred to as ERBB-2. In some people, the HER2 gene begins to mutate or change, which can be a driving cause of cancer. HER2 mutations occur in about 2 out of every 100 cases (2%) of non-small cell lung cancers (NSCLC).

On September 9, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Hyrnuo (sevabertinib) for people with locally advanced or metastatic, non-squamous NSCLC whose tumors have a HER2 (ERBB-2) activating mutation.  

This approval expands the FDA’s previous approval of Hyrnuo (sevabertinib) from November 2025 by making it a first-line treatment option for people with HER2-positive NSCLC.

This latest approval is based on the results of the SOHO-01 study, which looked at how safe and effective Hyrnuo (sevabertinib) is for people with locally advanced or metastatic, non-squamous NSCLC whose tumors have a HER2 activating mutation. Study participants who had not yet received systemic treatment received Hyrnuo (sevabertinib). They experienced both a promising response rate and benefits that lasted for a meaningful time period in those who responded to treatment.

This is an exciting update from the FDA because it gives people with locally advanced or metastatic, non-squamous NSCLC whose tumors have a HER2 activating mutation another first-line therapy treatment option.

Please speak with your healthcare team for more information about Hyrnuo (sevabertinib) and to see if it may be an option for you. If you have questions about treatment, trials, or biomarker testing, contact our LungMATCH team at support@go2.org or 1-800-298-2436.  

Read the  full FDA announcement.