For certain patients with EGFR+ NSCLC after surgery

Biomarker testing

Understand how biomarker tests can ensure the correct diagnosis for your specific form of cancer

Test for EGFR mutations to help find treatment options right for you

A lung cancer diagnosis can be overwhelming. Following surgery to remove your tumor, what's one of the first steps to determine your next steps in treatment? Start by asking your doctor to test for EGFR mutations. Knowing your EGFR mutation test results can help your doctor recommend the right treatment options.

What is biomarker testing?

What is biomarker testing?

Non-small cell lung cancer (NSCLC) biomarkers such as EGFR mutations, are molecules found on the surface of cells or in the genes that program the cells. Biomarkers can help doctors find out detailed information about a tumor and can help predict how well the body may respond to certain types of treatment.

What is biomarker testing?

Biomarker testing goes by many names. Some of the most common are: mutation testing genetic testing molecular testing genomic testing

Biomarker test results may reveal what’s causing your type of lung cancer to grow and spread. If an EGFR mutation is driving your lung cancer, you may be able to treat it by targeting that specific mutation.

How do doctors test for biomarkers?

How do doctors test for EGFR mutations?

Doctors often test for biomarkers, including EGFR mutations, with a biopsy. This is where tissue is removed from a tumor so it can be tested. EGFR mutation testing can occur after first diagnosing lung cancer, or at any time thereafter—including as part of surgery when the tumor is removed.

When will I receive my EGFR mutation test results?

It may take up to a few weeks to get your EGFR mutation testing results. A complete diagnosis takes the results from biomarker testing into consideration. This can be crucial in helping your doctor determine which treatment options are right for your type of lung cancer.

Biomarker testing can help your doctor find the right treatment optionsBiomarker testing can help your doctor find the right treatment options for you.
About 1 in 4 people with NSCLC have cancer that tests positive for the EGFR biomarker* About 1 in 4 people with NSCLC have cancer that tests positive for the EGFR biomarker *Based on data from a clinical trial; Sholl et al (2015) performed mutation analysis on 1007 specimens with confirmed diagnosis of lung adenocarcinoma in a
multi-site US-based study.

EGFR: a common NSCLC biomarker

There are many NSCLC biomarkers but some are more common than others.

Epidermal Growth Factor Receptor (EGFR) is a common NSCLC biomarker, especially in adenocarcinomas. EGFR helps cells grow and divide normally. But mutated EGFR on the surface of certain cancer cells sends signals that cause the cancer to grow and spread. Targeted therapies may block these signals to help prevent cancer from recurring after surgery.

For EGFR+ NSCLC patients after surgery, there is currently only one EGFR-TKI therapy available: TAGRISSO.

About 1 in 4 people with NSCLC have cancer that tests positive for the EGFR biomarker* About 1 in 4 people with NSCLC have cancer that tests positive for the EGFR biomarker *Based on data from a clinical trial; Sholl et al (2015) performed mutation analysis on 1007 specimens with confirmed diagnosis of lung adenocarcinoma in a multi-site US-based study.
Why it’s critical to treat your type of lung cancer

Why it’s critical to treat your type of lung cancer

Once you know the type of lung cancer you have from biomarker testing, partner with your doctor to choose a treatment option that's proven to help prevent your cancer from coming back following surgery.

If your cancer tests positive for an EGFR mutation, the proven treatment option is a targeted therapy called an EGFR tyrosine kinase inhibitor (TKI). TAGRISSO is the only FDA-approved EGFR TKI treatment for people with EGFR+ NSCLC following tumor removal.

TAGRISSO is proven to target and block what causes EGFR+ non-small cell lung cancer to grow and spread. If EGFRm is driving your lung cancer, you want to make sure your treatment targets EGFR.

Biomarker testing can help ensure you get the most appropriate treatment option for your type of cancer.

TAGRISSO is the only EGFR-TKI therapy for people with EGFR+ NSCLC following tumor removal.

Lung cancer treatment checklist

It’s important to take the following steps before starting treatment:

1

Be sure to see an oncologist. Even after surgery to remove tumors, there’s a chance that cancer can return. It’s important to see an oncologist following surgery to ensure your condition is properly monitored.

2

Talk to your doctor about getting tested for EGFR mutations and make an appointment to discuss the results with your doctor.

3

Talk to your doctor about your test results so you know what may be driving the growth and spread of your lung cancer.

4

Select the right treatment option with your doctor based on your EGFR mutation test results.

TAGRISSO safety information
TAGRISSO clinical trial results

In a clinical study, TAGRISSO was proven to work for people with Stage 1B, 2, and 3A EGFR+ NSCLC following complete tumor removal by surgery.

See the results
TAGRISSO is a once-daily pill

TAGRISSO is a once-daily pill for EGFR+ non-small cell lung cancer after surgery.

Learn more about TAGRISSO

A disease in which abnormal cells divide out of control, at a very fast rate. These abnormal cells can spread to other nearby organs and tissues.

A biological molecule found in blood, other body fluids, or tissues. A biomarker is a sign of a normal or abnormal process, or of a condition or disease. Biomarkers for stage 4 NSCLC can include EGFR, ALK, PD-L1, BRAF, ROS1, and NTRK. Testing for biomarkers is an important part of a complete stage 4 NSCLC diagnosis.

A group or layer of cells that work together to perform a specific function.

An abnormal growth of cells that may be benign (not cancer) or malignant (cancer).

A protein found on the surface of some cells. When EGFR mutates, it plays a role in causing cancer cells to grow excessively and spread as tumors. EGFR is one of the stage 4 NSCLC biomarkers.

A gene that makes a protein called anaplastic lymphoma kinase (ALK), which may be involved in cell growth. Mutated (changed) forms of the ALK gene and protein have been found in some types of cancer.

PD-1 is a protein found on T cells (a type of immune cell) that helps keep the body’s immune responses in check. When PD-1 is bound to another protein called PD-L1, it helps keep T cells from killing other cells, including cancer cells.

A gene that makes a protein called B-RAF, which is involved in sending signals in cells and in cell growth. This gene may be mutated (changed) in many types of cancer, which causes a change in the B-RAF protein. This can increase the growth and spread of cancer cells.

A gene that makes a protein called ROS1, which is involved in sending signals in cells and in cell growth. Mutated (changed) forms of the ROS1 gene have been found in some types of cancer.

A gene that makes a protein called KRAS, which is involved in cell signaling pathways that control cell growth, cell maturation, and cell death.

A gene carries information about traits passed from parent to child. Most contain instructions for making a specific protein.

A cancer that starts in cells found in tissues that line certain organs, such as the lungs or breast.

Important Safety Information

TAGRISSO may cause serious side effects, including:

  • lung problems. TAGRISSO may cause lung problems that may lead to death. Symptoms may be similar to symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever
  • heart problems, including heart failure. TAGRISSO may cause heart problems that may lead to death. Your healthcare provider should check your heart function before you start taking TAGRISSO and during treatment as needed. Tell your healthcare provider right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded
  • eye problems. TAGRISSO may cause eye problems. Tell your healthcare provider right away if you have symptoms of eye problems which may include watery eyes, sensitivity to light, eye pain, eye redness, or vision changes. Your healthcare provider may send you to see an eye specialist (ophthalmologist) if you get eye problems with TAGRISSO
  • skin problems. TAGRISSO may cause skin problems. Tell your healthcare provider right away if you develop target lesions (skin reactions that look like rings), severe blistering or peeling of the skin
  • Inflammation of your blood vessels in your skin. TAGRISSO may cause blood vessel problems in your skin. Tell your healthcare provider right away if you develop purple spots or redness of the skin that does not fade in color when pressed (non-blanching) on your lower arms, lower legs, or buttocks or large hives on the main part of your body (trunk) that do not go away within 24 hours and look bruised.
Important Safety Information

TAGRISSO may cause serious side effects, including:

  • lung problems. TAGRISSO may cause lung problems that may lead to death. Symptoms may be similar to symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever
  • heart problems, including heart failure. TAGRISSO may cause heart problems that may lead to death. Your healthcare provider should check your heart function before you start taking TAGRISSO and during treatment as needed. Tell your healthcare provider right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded
  • eye problems. TAGRISSO may cause eye problems. Tell your healthcare provider right away if you have symptoms of eye problems which may include watery eyes, sensitivity to light, eye pain, eye redness, or vision changes. Your healthcare provider may send you to see an eye specialist (ophthalmologist) if you get eye problems with TAGRISSO
  • skin problems. TAGRISSO may cause skin problems. Tell your healthcare provider right away if you develop target lesions (skin reactions that look like rings), severe blistering or peeling of the skin
  • inflammation of the blood vessels in your skin. TAGRISSO may cause blood vessel problems in your skin. Tell your healthcare provider right away if you develop purple spots or redness of the skin that does not fade in color when pressed (non-blanching) on your lower arms, lower legs, or buttocks or large hives on the main part of your body (trunk) that do not go away within 24 hours and look bruised

Before taking TAGRISSO, tell your healthcare provider about all of your medical conditions, including if you:

  • have lung or breathing problems
  • have heart problems, including a condition called long QTc syndrome
  • have problems with your electrolytes, such as sodium, potassium, calcium or magnesium
  • have a history of eye problems
  • are pregnant or plan to become pregnant. TAGRISSO can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with TAGRISSO or think you may be pregnant
    • Females who are able to become pregnant should have a pregnancy test before starting treatment with TAGRISSO. You should use effective birth control during treatment with TAGRISSO and for 6 weeks after the final dose of TAGRISSO
    • Males who have female partners that are able to become pregnant should use effective birth control during treatment with TAGRISSO and for 4 months after the final dose of TAGRISSO
  • are breastfeeding or plan to breastfeed. It is not known if TAGRISSO passes into your breast milk. Do not breastfeed during treatment with TAGRISSO and for 2 weeks after your final dose of TAGRISSO. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your healthcare provider if you take a heart or blood pressure medicine

The most common side effects of TAGRISSO are:

  • low white blood cell counts
  • low platelet counts
  • diarrhea
  • low red blood cell counts (anemia)
  • rash
  • muscle, bone, or joint pain
  • changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from nailbed, and shedding of nail
  • dry skin
  • mouth sores
  • tiredness
  • cough

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TAGRISSO. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-fda-1088.

What is TAGRISSO?

TAGRISSO is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has certain abnormal epidermal growth factor receptor (EGFR) gene(s):

  • to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery, or
  • as your first treatment when your lung cancer has spread to other parts of the body (metastatic), or
  • when your lung cancer has spread to other parts of the body (metastatic) and you have had previous treatment with an EGFR tyrosine kinase inhibitor (TKI) medicine that did not work or is no longer working

Your healthcare provider will perform a test to make sure that TAGRISSO is right for you.

It is not known if TAGRISSO is safe and effective in children.

Please see complete Prescribing Information, including Patient Information.

You may report side effects related to AstraZeneca products by clicking here.