Did you know? HER2 is a gene found in cells that is important for cell growth and survival. You may also sometimes see HER2 referred to by the name ERBB-2. In some people, the HER2 gene begins to change or mutate, which can be a driving cause of lung cancer. There are different types of mutations in HER2 for lung cancer, but the most common change occurs when new information is inserted into a specific part of the HER2 gene called exon 20. HER2 mutations occur in about 2 out of every 100 cases (2%) of non-small cell lung cancers (NSCLC).

On November 19, 2025, the U.S. Food and Drug Administration (FDA) announced the accelerated approval of Hyrnuo (sevabertinib) for people with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) whose tumors have a HER2 (ERBB-2) activating mutation and have already received systemic therapy, such as chemotherapy.  

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 in the tyrosine kinase domain (a region of the HER2 gene that helps control cell growth signals). Study participants who received Hyrnuo (sevabertinib) after previously receiving systemic therapy experienced both an encouraging response rate and benefits from treatment that lasted for a meaningful period of time. This is encouraging news for people with an uncommon HER2 NSCLC mutation who have progressed on systemic therapy and are looking for a new treatment option.   

Hyrnuo (sevabertinib) is a type of targeted therapy treatment known as a tyrosine kinase inhibitor (TKI), which works by blocking the activity of mutated HER2 in cancer cells and may help to slow down or stop their growth.   

Please speak with your healthcare team for more information about Hyrnuo (sevabertinib) and to see if it may be a good 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.