How ALUNBRIG^® (brigatinib) May Help as Your First-Line Treatment for ALK+ Metastatic Non-Small Cell Lung Cancer

[Katie]

Before my diagnosis, I really thought of myself as a pretty healthy person. I took care of myself. I have never been a smoker. I never had any major health issue or problem.
My name is Katie. I live in a suburb of Chicago. I'm married to my wonderful husband, Tom, and I have two great kids, Wilson and Opal.

I was diagnosed with ALK positive, metastatic non-small cell lung cancer in January of 2022. About a year before I was actually diagnosed, I developed a cough and it would not go away. I tried everything. I went and sought out my doctor, and at first she thought that it was possibly allergies. And she said, “Let's just keep an eye on it, and we'll follow up after the holidays.”

And at that appointment, I learned that they were able to see a mass in my lower left lung. My doctor tried to reassure me this could be so many things. But just in case, we should do a PET scan. And on the PET scan, it lights up in areas that could be metastatic. I had light up along my spine, in my left shoulder, in my lymph nodes, in my left lung, my lower back.

20 minutes or so after I woke up from surgery, the surgeon came in and confirmed that it was stage four, non-small cell lung cancer. People around me were trying so hard to be positive, I didn't understand what had happened. I didn't understand why it had happened. I was really clutching for answers that just really aren't there. We talked about the possibility, because I was young and a non-smoker, there was a higher likelihood that I would have a targetable mutation that was driving the cancer.

Instead of traditional chemotherapy and radiation, there are certain mutations that just require an oral pill.

So we're waiting for the phone call from the doctor to let me know if I have this mutation or not.

The phone rang, and it was the doctor, and she said, I have great news. You have a mutation called ALK.

There is a treatment path available to you. The sense of relief I had was just unlike anything I had felt.

In a cancer diagnosis a second opinion is everything. My doctor sat down with my husband and myself and actually went over three possible options for my treatment. My doctor and I both decided that ALUNBRIG would be the best choice for me. I have a busy life and taking one pill a day doesn't seem to be very intrusive to my life.

ALUNBRIG is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has a certain type of abnormal anaplastic lymphoma kinase (ALK) gene, and that has spread to other parts of your body. It is not known if ALUNBRIG is safe and effective in children. I started ALUNBRIG with 90 milligrams once a day for seven days, and then I increased it to 180 milligrams once a day, which is the recommended dose, and that's the dose I continue to be on. 
Since being on ALUNBRIG, I have not had too many side effects, but I have experienced some GI side effects, which I've been able to manage with my doctor and with over-the-counter medication. 
But these are not all of the possible side effects and everyone is different. Speak to your health care provider about the potential side effects with ALUNBRIG.

After my one-year PET scan on ALUNBRIG, my doctor just gave me the biggest hug, and she said, I have to tell you, you have had a complete metabolic response… and you have no evidence of disease currently in your body. 
Being able to just continue with what I did as a mom, as a wife, that's meant everything. My husband has held me up through all of it. My kids have inspired me to keep going. I saw my son graduate high school. I moved my son into his dorm room. That was big. My daughter, Sweet 16. I'm going to be 50 this year.
I want to travel. I want to see things. I want to visit places that I've always wanted to go. 
Today, I feel healthy, I feel confident, I feel grateful.
For me, ALUNBRIG means hope.

ALUNBRIG (brigatinib) is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC):
• that has a certain type of abnormal anaplastic lymphoma kinase (ALK) gene, and
• that has spread to other parts of your body
It is not known if ALUNBRIG is safe and effective in children.

ALUNBRIG can cause serious side effects, including:
Lung problems. ALUNBRIG may cause severe or life-threatening swelling (inflammation) of the lungs any time during treatment and can lead to death. These lung problems happen especially within the first week of treatment with ALUNBRIG. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms, including:
• trouble breathing or shortness of breath
• chest pain
• cough with or without mucus
• fever

High blood pressure (hypertension). ALUNBRIG may cause high blood pressure. Your healthcare provider will check your blood pressure before starting and during treatment with ALUNBRIG. Tell your healthcare provider right away if you get headaches, dizziness, blurred vision, chest pain or shortness of breath.

Slow heart rate (bradycardia). ALUNBRIG may cause very slow heartbeats that can be severe. Your healthcare provider will check your heart rate during treatment with ALUNBRIG. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint during treatment with ALUNBRIG. Tell your healthcare provider if you take any heart or blood pressure medicines.

Vision problems. ALUNBRIG may cause vision problems. Your healthcare provider may stop ALUNBRIG and refer you to an eye specialist if you develop severe vision problems during treatment with ALUNBRIG. Tell your healthcare provider right away if you have any loss of vision or any change in vision, including:
• double vision
• seeing flashes of light
• blurry vision
• light hurting your eyes
• new or increased floaters

Muscle pain, tenderness, and weakness (myalgia). ALUNBRIG may increase the level of an enzyme in your blood called creatine phosphokinase (CPK), which may be a sign of muscle damage. Your healthcare provider will do blood tests to check your blood levels of CPK during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.

Inflammation of the pancreas (pancreatitis). ALUNBRIG may increase enzymes in your blood called amylase and lipase, which may be a sign of pancreatitis. Your healthcare provider will do blood tests to check your pancreatic enzyme blood levels during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs and symptoms of pancreatitis, including upper abdominal pain that may spread to the back and get worse with eating, weight loss, or nausea.
Liver problems (hepatotoxicity). ALUNBRIG may increase the levels of bilirubin in your blood and enzymes called aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in your blood, which may be a sign of liver problems. Your healthcare provider will do blood tests to check your liver during treatment with ALUNBRIG. Tell your healthcare provider right away if you get new or worsening signs or symptoms, including:
• yellowing of your skin or the white part of your eyes
• dark or brown (tea color) urine
• nausea or vomiting
• pain on the right side of your stomach area
• bleed or bruise more
• itchy skin
• decreased appetite
• feeling tired

High blood sugar (hyperglycemia). ALUNBRIG may increase your blood sugar levels. Your healthcare provider will do blood tests to check your blood sugar levels before starting and during treatment with ALUNBRIG. Your healthcare provider may need to start or change your blood sugar medicine to control your blood sugar levels. Tell your healthcare provider right away if you get new or worsening signs and symptoms of hyperglycemia, including:
• feeling very thirsty
• needing to urinate more than usual
• feeling very hungry
• feeling sick to your stomach
• feeling weak or tired
• feeling confused

The most common side effects of ALUNBRIG include diarrhea, fatigue, nausea, rash, cough, muscle pain, headache, high blood pressure, vomiting and difficulty breathing.

ALUNBRIG may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of ALUNBRIG. Call your doctor for medical advice about side effects.  You may report side effects to the FDA at 1-800-FDA-1088.

While taking ALUNBRIG you should:
• Limit your time in the sun during treatment with ALUNBRIG and for at least 5 days after your final dose. ALUNBRIG may make your skin sensitive to sunlight. You may burn more easily and get severe sunburns. When you are in the sun, wear a hat and protective clothing, and use a broad-spectrum sunscreen and lip balm with a Sun Protection Factor (SPF) of 30 or greater to protect against sunburn.
• Avoid eating grapefruit or drinking grapefruit juice during treatment with ALUNBRIG. Grapefruit may increase the amount of ALUNBRIG in your blood.

Before you take ALUNBRIG, tell your healthcare provider about all of your medical conditions, including if you have lung or breathing problems, high blood pressure, a slow heartbeat, or any vision problems, have or have had pancreatitis, have liver problems, have diabetes mellitus or glucose intolerance, have kidney problems or are on dialysis, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.
• ALUNBRIG can harm your unborn baby. Your healthcare provider will determine whether or not you are pregnant before you start treatment with ALUNBRIG. Tell your healthcare provider right away if you become pregnant during treatment with ALUNBRIG or think you may be pregnant.
• Females who are able to become pregnant should use effective birth control during treatment with ALUNBRIG and for at least 4 months after the final dose of ALUNBRIG. Talk to your healthcare provider about birth control choices that are right for you during treatment with ALUNBRIG.
• Males who have female partners who are able to become pregnant should use effective birth control during treatment with ALUNBRIG and for at least 3 months after the final dose of ALUNBRIG.
• It is not known if ALUNBRIG passes into your breast milk. Do not breastfeed during treatment with ALUNBRIG and for 1 week after the final dose of ALUNBRIG.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements.

Talk to your healthcare provider about ALUNBRIG, a once-daily oral prescription medication that may help treat adults with ALK-positive metastatic non-small cell lung cancer.