What Is ALK+ Non-Small Cell Lung Cancer (NSCLC)?

A diagnosis of ALK+ NSCLC can raise a lot of questions.
Let’s start by answering the basics.

What Is Non-Small Cell Lung Cancer?

Non-small cell lung cancer, or NSCLC, is the most common type of lung cancer. It makes up about 80-85% of lung cancer cases.

In some cases of NSCLC, a genetic change, or mutation, in the cell’s genes causes the cell to function improperly and grow more quickly, which may lead to cancer.

What Does ALK-Positive Mean?

In some people, lung cancer is caused by a change in the structure of the gene called anaplastic lymphoma kinase (ALK). About 3% to 5% of people with NSCLC have this change in the ALK gene. This type of lung cancer is most frequently seen in non-smokers or light smokers and younger patients.

How Can Targeted Therapies Help?

Although there is no cure, ALK+ (anaplastic lymphoma kinase-positive) metastatic NSCLC can be treated with targeted therapies that affect this specific gene found in cancer cells to help block the growth or spread of cancer. These therapies are known as tyrosine kinase inhibitors (TKI) or ALK inhibitors.

What if ALK+ NSCLC Has Spread Beyond Your Lungs?

ALK+ NSCLC Metastasis

ALK-positive NSCLC is a disease that often progresses beyond the lungs. Progression is when tumors grow, spread to other parts of the body (called metastasis), or when new tumors develop while on treatment. When cancer progresses, it can spread to many locations, including the liver, bone, and the brain.

With ALK+ NSCLC, Your Brain Matters Too

Because current treatments are more effective and people with ALK-positive NSCLC live longer without disease progression, up to 75% of patients may eventually experience the disease traveling to their brains.

ALK+ NSCLC can metastasize to other areas of the body including the brain, liver, or bones.

How ALUNBRIG Works

It's normal to have questions as you begin your treatment on ALUNBRIG.

We have additional resources for you to discuss with your healthcare provider as you get started.

See Additional Resources

Glossary

ALK gene - A gene that makes a protein called anaplastic lymphoma kinase or ALK, which is involved in cell growth. Mutated or genetically changed forms of the ALK gene and protein have been found in some types of cancer, such as NSCLC.
Metastasis - The spread of cancer from the original site to another part of the body.

Targeted therapies - A type of treatment that can inhibit or slow the disease growth, progression, and spread of cancer by targeting specific molecules that are responsible for cancer cell growth. Some targeted therapies block the action of certain enzymes, proteins, or other molecules involved in the growth and spread of cancer cells.

IMPORTANT SAFETY INFORMATION

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 easily than normal
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.

What should I avoid while taking ALUNBRIG?

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.