Non-small-cell lung cancer (NSCLC) is the most common type of lung cancer. If you have been diagnosed with NSCLC, your health care provider may test your cancer to see if it has certain genetic changes. Some treatments are designed to target specific genetic changes in cancer cells and are more likely to be effective tools to fight the disease when those mutations are present.
In July 2025, the FDA approved Zegfrovy (sunvozertinib) for certain people with NSCLC. Zegfrovy is for people whose NSCLC has a certain genetic change, called an epidermal growth factor receptor (EGFR) exon 20 insertion mutation.
How Does Zegfrovy Work?
EGFR is a protein on the surface of cells that helps them to grow and multiply. In some people with NSCLC, there is a specific change in the EGFR gene known as an “exon 20 insertion mutation.” Zegfrovy is a type of medicine called a kinase inhibitor. It attaches to the mutant EGFR protein with the exon 20 insertion mutation and turns the protein off. This causes EGFR to quit sending the signal to cells to grow and multiply, which causes the cells to die and can cause tumors to shrink in size.
Is Zegfrovy Right for Me?
Your health care provider will perform a test to make sure that Zegfrovy is right for you. Zegfrovy may be a good choice for you if you have NSCLC that has the EGFR exon 20 insertion mutation and your cancer has gotten worse during or after chemotherapy.
Zegfrovy has not been studied in people with NSCLC who have certain health problems, including serious heart or lung problems, serious infections, or severe stomach or intestinal problems. Additionally, treatment with Zegfrovy may not be the best option for people who have recently received certain other cancer treatments.
How Do I Use Zegfrovy?
Zegfrovy is a tablet that is swallowed. You will take your Zegfrovy dose once a day with food to reduce stomach problems that might happen with the medicine. Try to take it around the same time every day. Setting an alarm may help you to take every 24 hours. You may stay on Zegfrovy if it is helping your cancer and is not hurting you by causing serious side effects.
How Was Zegfrovy Studied?
A clinical study was done to see if Zegfrovy was safe and effective for the treatment of NSCLC. To be eligible for the study, people had to have NSCLC with a specific genetic change called EGFR exon 20 insertion mutation. All people in the study had NSCLC that got worse during or after chemotherapy. People in the study received either 200 milligrams or 300 milligrams of Zegfrovy once daily and continued the medicine until their cancer got worse or they could not tolerate the side effects.
As of January 2024, a total of 184 adults were included in the study from multiple countries. People who got the approved dose of 200 milligrams daily were between the ages of 35 and 88, and 67% were women. Most were Asian (65%) or White (33%); 2% did not report their race or reported a race of “other.” Most (71%) of the participants had never smoked. Zegfrovy was evaluated by shrinkage or disappearance of the tumor (overall response rate) and how long the tumors stayed smaller after treatment (duration of response).
What Are the Main Benefits Based on the Study?
Of the 85 people, 40% had tumor shrinkage (partial response), and 6% had tumor disappearance (complete response). So the overall response rate was 46%. Most (74.6%) of people who responded to treatment with Zegfrovy were still responding. Thus, the duration of response has not yet been reached.
Some people had stable disease with Zegfrovy treatment. Overall, 90.8% had stable disease, complete response, or partial response. Confirmation of responses is ongoing.
Your results may differ from what was seen in clinical studies.
How Strong Is the Evidence for Zegfrovy?
Zegfrovy was approved by the FDA through a special process called "accelerated approval." This means the FDA approved the medication based on early promising results showing that it can shrink tumors and keep them smaller for a period of time. Additional studies are needed to confirm the benefits of Zegfrovy.
What Can I Do to Manage Side Effects?
The most common side effects of Zegfrovy include diarrhea, rash, and decreased appetite. Tell your health care provider right away if you have stomach problems with treatment, including nausea, vomiting, and diarrhea. Your health care provider may recommend medicines that can help with your symptoms. There are electrolyte replacement products to help prevent or treat dehydration. For diarrhea or nausea, there are both prescription and over-the counter (OTC) medicines that may be used. Take any medicine that your health care provider prescribes or recommends for you.
Use alcohol-free emollient creams during treatment with Zegfrovy to help prevent skin problems. Avoid harsh skin products that could irritate your skin, such as those containing retinol, retinoic acid, or benzoyl peroxide. If you get skin rashes or other skin problems, tell your health care provider right away.
Watch for new or worsening breathing problems like shortness of breath, cough, or fever. These could be signs of serious lung inflammation. If you notice any of these symptoms, contact your health care provider right away.
If you get new or worsening eye problems, tell your health care provider right away so that you can be referred to an eye specialist (ophthalmologist). If you wear contact lenses, do not use them until your eye problems have been checked by a health care provider and at least one week has passed since your eye symptoms have gone away.
Based on how severe your side effects are, your health care provider may need to pause your treatment, change your dose, or stop Zegfrovy.
