FDA Approves Hyrnuo as First Treatment Choice for Specific Type of Lung Cancer

What Is Hyrnuo and How Does It Work?

The FDA has granted accelerated approval to Hyrnuo (sevabertinib) for adults with a specific type of advanced lung cancer.

It is used for non-squamous non-small-cell lung cancer (NSCLC) that has spread in the chest or to other parts of the body.

To receive this drug, a special test must show that the cancer cells have a specific gene change called a HER2 mutation.

Hyrnuo is now approved as a first-line treatment. The previous indication approved in 2025 required patients to receive other systemic treatment before Hyrnuo. Hyrnuo belongs to a group of medicines known as kinase inhibitors. It works by blocking certain proteins that tell cancer cells to grow and multiply. By blocking these proteins, Hyrnuo helps slow down or stop the spread of cancer cells in the body.

Why Was Hyrnuo Approved?

The approval was based on results from a clinical study called SOHO-01. Researchers evaluated Hyrnuo in 69 adult patients with HER2-mutated advanced lung cancer who had not received prior cancer treatments. In this group, 75% of patients saw their tumor shrink or disappear. Specifically, 6% of patients had a complete response with no visible tumor, while 70% had a partial response. Among those who had a response to the medicine, 73% maintained their response for at least six months, and 38% maintained it for over 12 months.

The drug was also studied in patients who had already tried other cancer therapies. For patients previously treated without HER2-targeted therapy, 71% had a response to treatment. For patients who had previously received HER2-targeted antibody drug conjugates, 38% had a response. Serious side effects occurred in 33% of patients across the trial groups, with severe diarrhea and vomiting being among the most common. The FDA approved Hyrnuo under an accelerated process based on these promising early response rates, but continued approval may require proof of benefits in an ongoing study.

What Do I Need to Know About Taking Hyrnuo?

Hyrnuo comes as an oral tablet that is taken twice a day with food. You should swallow the tablets whole without cutting, crushing, or chewing them. Avoid eating grapefruit or drinking grapefruit juice while taking Hyrnuo, as it can change how the drug works in your body. Always tell your healthcare provider about all prescription drugs, over-the-counter medicines, and herbal supplements you take.

The most common side effects of Hyrnuo include diarrhea, skin rash, nail infections or inflammation, mouth sores, nausea, and vomiting. Diarrhea is very common and often starts during the first week of treatment. Your healthcare provider may advise you to keep diarrhea medicine on hand and drink plenty of fluids. Hyrnuo can also cause severe complications involving the liver, lungs, heart, eyes, or pancreas. Your healthcare provider will monitor your blood tests, heart, and liver health regularly.Hyrnuo can cause harm to a fetus. If you can get pregnant, you will need a negative pregnancy test before starting treatment and must use effective birth control during treatment and for one week after the last dose. If you can get a partner pregnant, you should also use effective birth control during treatment and for one week after the last dose. Do not breastfeed while taking Hyrnuo and for one week after your final dose.