FDA Approves Hernexeos (zongertinib) for HER2-Mutated NSCLC
August 11, 2025
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 February 26, 2026, the U.S. Food and Drug Administration (FDA) expanded its accelerated approval of Hernexeos (zongertinib) for people with advanced non-squamous non-small cell lung cancer (NSCLC) that has a HER2 activating mutation. This exciting update marks the first HER2-targeting therapy approved for use as the initial treatment for this population.
The previous approval allowed individuals to receive Hernexeos (zongertinib) only after a person had already received systemic treatment, such as chemotherapy. With this expanded approval, Hernexeos (zongertinib) can now be used as the first treatment for people with advanced non-squamous NSCLC that has a HER2 activating mutation.
This latest approval is based on the results of the Beamion LUNG-1 study, which evaluated the safety and effectiveness of Hernexeos (zongertinib) in people:
- Whose cancer could not be removed by surgery (unresectable)
- Whose cancer has spread (metastatic) and has a HER2-activating mutation
- Who had not previously received 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.
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.
Lung cancer questions? Contact our free HelpLine at support@go2.org or 1-800-298-2436.