Did you know? EGFR is a gene found in cells that is important for cell growth and survival. In some people, the EGFR gene begins to mutate or change, which can be a driving cause of cancer. There are many different types of changes in EGFR for lung cancer, such as when new genetic information is inserted into a part of the EGFR gene called exon 20. When this occurs, it’s called an EGFR exon 20 insertion. EGFR exon 20 insertions occur in about 4 out of every 100 cases (4%) of non-small cell lung cancer (NSCLC).  

On July 2, 2025, the U.S. Food and Drug Administration (FDA) announced the accelerated approval of Zegfrovy (sunvozertinib) for people with locally advanced or metastatic NSCLC who have an EGFR exon 20 insertion and have previously received chemotherapy.  

This latest approval is based on the results of the WU-KONG1B study, which looked at how safe and effective Zegfrovy (sunvozertinib) is for people with locally advanced or metastatic NSCLC who have an EGFR exon 20 insertion and have progressed after receiving chemotherapy. The study showed both a promising response rate and a response to treatment that lasted a meaningful amount of time for participants in the trial. This is encouraging news for people with a rare NSCLC mutation who have progressed and may have limited treatment options.  

Zegfrovy (sunvozertinib) is a type of treatment known as a tyrosine kinase inhibitor (TKI), which works by blocking the altered EGFR gene caused by the insertion and can help to slow down or stop the growth of cancer cells.  

Please speak with your healthcare team for more information about Zegfrovy (sunvozertinib) 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.