What Is Lyrfigtu and How Does It Work?
The FDA has approved Lyrfigtu (lirafugratinib) to treat adults with advanced bile duct cancer, also called cholangiocarcinoma. It is used when the cancer cannot be removed with surgery, has spread to nearby tissue or other parts of the body, and has already been treated with chemotherapy. This medicine is specifically for people whose cancer cells have a specific genetic change called an FGFR2 gene fusion or other rearrangement. Your healthcare provider will test your tumor to see if you have this gene change before starting treatment.
Bile duct cancer affects the small tubes that carry digestive fluid from your liver to your gallbladder and small intestine. FGFR2 is a protein that normally helps cells grow. When the FGFR2 gene changes or fuses, it sends constant signals that cause cancer cells to multiply and spread.
Lyrfigtu is a targeted therapy known as a kinase inhibitor. It works by attaching directly to the changed FGFR2 protein and blocking its growth signals. This can help slow cancer growth and shrink tumors.
Why Was Lyrfigtu Approved?
The FDA approved Lyrfigtu based on a clinical trial called REFOCUS. The study included 116 adults with advanced bile duct cancer and FGFR2 gene changes who had previously received chemotherapy. Everyone in the study took Lyrfigtu once daily.
Researchers measured how many patients had their tumors shrink and how long that shrinkage lasted. In the trial, 46% of patients saw their tumors shrink. For those who had a response, the tumor shrinkage lasted for a median of 11.8 months. More than 60% of people who had a response maintained it for six months or longer.
Most people in the study had side effects, but many were managed with dose adjustments or short breaks from treatment. Serious safety risks were identified during the study, including eye problems and high blood phosphate levels, which require close monitoring during treatment.
What Do I Need to Know About Lyrfigtu?
Lyrfigtu comes as a capsule that you take by mouth once daily, with or without food. Swallow the capsules whole. Do not open, break, or chew them.
This medicine can cause severe eye problems, including detachment of the retina, blurred vision, dry eyes, and corneal damage. You will need a full eye exam before starting Lyrfigtu — every two months for the first 13 months and every four months after that. Contact your healthcare provider immediately if you notice any visual changes, such as blurred vision. Using artificial tears or hydrating eye gels can help prevent or treat dry eyes.
Another common risk is high levels of phosphate in your blood, which can cause calcium deposits to form in your soft tissues or blood vessels. Your healthcare provider will monitor your blood phosphate levels during treatment. Tell your healthcare provider right away if you experience muscle cramps, numbness, or tingling around your mouth. Other common side effects include nail problems, hand-foot skin reaction (redness or swelling on the palms and soles), mouth sores, hair loss, tiredness, dry skin, taste changes, constipation, abdominal pain, diarrhea, and nausea. This medicine can also make your skin more sensitive to sunlight, so use sunscreen, wear protective clothing, and limit sun exposure.
Lyrfigtu can harm a fetus. If you can get pregnant, do use effective birth control during treatment and for six months after your last dose. If you can get a partner pregnant, you should use effective birth control during treatment and for three months after your last dose. Do not breastfeed while taking Lyrfigtu and for one week after your last dose. Tell your healthcare provider about all medicines you take, as some drugs can affect how this medicine works.