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.
It has been slightly over a month since Zegfrovy has been approved by the FDA. However, it does not appear to be available in the US. What is distribution plan?
Hi Katarzyna – Great question! Any time a new drug receives FDA approval, there is usually a gap in time between when that drug is approved and when it becomes available to qualifying individuals. This is primarily because, following approval, companies still have to finalize manufacturing, distribution logistics, pricing strategies, and patient access programs. For a drug like Zegfrovy, which was granted accelerated approval, rather than full approval (more details in the link below, if you’re interested), companies receive increased monitoring from the FDA to verify and describe the drug’s benefit in the real world, so they tend to be even more cautious in their distribution of the drug, so as to not have the approval withdrawn. In terms of Dizal’s specific distribution plan for Zegfrovy, I’m sorry to say that there’s no clear public information about that yet. It can be frustrating to hear about an approval and not see the treatment widely available yet. You may be able to speak with your healthcare team for more information about Zegfrovy’s availability and to see if it may be a good option for you or a loved one. If you have other questions about Zegfrovy, or about other treatments, trials, or biomarker testing, contact our LungMATCH team at support@go2.org or 1-800-298-2436.
For more details on FDA approvals: https://go2.org/blog/fast-tracking-innovation-the-fdas-process-for-approving-new-cancer-therapies/