What Is Hernexeos, and Why Does It Matter?
Hernexeos (zongertinib) is a new pill for adults with a type of advanced lung cancer called non-small-cell lung cancer (NSCLC) that has a HER2 gene mutation that causes the cancer to grow and spread faster, especially to the brain. Hernexeos belongs to a group of medicines called tyrosine kinase inhibitors that work by blocking the activity of a faulty HER2 protein, which may help slow or stop the growth of HER2-mutant cancer cells.
This is the first time the FDA has approved an oral treatment for this specific type of lung cancer in people who have already tried other therapies and whose cancer cannot be surgically removed or has spread to other parts of the body. A health care provider will need to confirm the HER2 mutation using an FDA-approved test (Oncomine Dx Target Test) before starting this therapy. Until now, treatment options for HER2-mutant NSCLC were limited, often involving intravenous therapies with considerable side effects. As a targeted oral treatment, Hernexeos may provide an alternative approach for these patients.
Why Was It Approved?
Hernexeos was approved through the FDA’s accelerated approval program, which allows earlier access to promising treatments for serious conditions. This type of approval is based on early results, and continued approval will depend on future studies that confirm how well the medicine works over time.
The FDA’s decision was based on a clinical trial studying how well Hernexeos works in people with HER2-mutant NSCLC who had tried other treatments but not HER2-targeted or any other antibody-drug conjugate therapies. In the study, about 75% patients saw their cancer respond to the medicine; among them, about 6% did not show any signs of cancer after treatment, while 69% saw their tumors shrink. More than half of those who responded stayed cancer-free (in remission) for at least six months.
For people who had already tried HER2-targeted therapy, 44% saw a response to Hernexeos, and about 1 in 4 stayed in remission for six months or longer.
The most common side effects reported in the study were diarrhea, liver issues, skin rashes, tiredness, nausea, and certain abnormal blood test values. Some rare but serious risks were also reported, such as liver damage, heart problems, and lung inflammation.
What Do I Need to Know?
Hernexeos is a pill you take by mouth once a day with or without food. The dose depends on your weight. If you weigh less than 90 kilograms (about 198 pounds), you’ll take a lower dose. If you weigh more, you’ll take a higher dose. Treatment continues as long as it’s working and the side effects are manageable.
You should not split, crush, or chew the tablets. If you miss a dose by more than 12 hours, skip it and take your next dose at the usual time. If you throw up after taking it, don’t take another dose — just wait until your next scheduled dose. Do not change your dose or schedule or stop taking Hernexeos without consulting your health care provider.
Your health care provider will also monitor you for possible side effects, including liver and heart problems, or lung inflammation. Contact medical services right away if you notice yellowing of your skin or the white part of your eyes (jaundice), tea-colored urine, a pounding or racing heartbeat, trouble breathing, or swelling in the legs, ankles, or feet. Hernexeos can also harm a fetus, so you should not take it if you are pregnant or planning to become pregnant. Use effective birth control while taking Hernexeos and for two weeks after your last dose. Do not breastfeed while on this medicine and for two weeks after your last dose.
Hernexeos may also interact with other drugs, especially those that affect how your liver processes medicine. Be sure to tell your health care provider about any other medicines you take, including over-the-counter medicines and supplements, to avoid harmful interactions. If you’ve already tried other treatments for NSCLC, talk with your provider to see if Hernexeos could be a good option.