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 mutate or change, which can be a driving cause of cancer. There are many different types of changes in HER2 for lung cancer, but the most common change occurs when new information is inserted in 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 August 8, 2025, the U.S. Food and Drug Administration (FDA) announced the accelerated approval Hernexeos (zongertinib) for people with advanced non-squamous non-small cell lung cancer (NSCLC) that has a HER2 gene change. It is for patients whose cancer cannot be removed by surgery (unresectable) or has spread (metastatic), and who have already had other systemic therapies. 

This latest approval is based on the results of the Beamion LUNG-1 study, which looked at how safe and effective Hernexeos (zongertinib) is for people with unresectable or metastatic, non-squamous NSCLC whose tumors have a HER2 activating mutation and have previously had systemic therapy. The study showed participants in the trial experienced both a promising response rate and, for those who responded, benefits lasted for a meaningful period of time. This is encouraging news for people with a rare NSCLC mutation who have progressed on systemic therapy and may have limited treatment options.  

Hernexeos (zongertinib) is a type of 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 Hernexeos (zongertinib) 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.