For certain patients with EGFR+ NSCLC after surgery

Clinical trial results

Following surgery, EGFR+ lung cancer may be more treatable than before

TAGRISSO is the first major breakthrough in post-surgery NSCLC treatment in 15 years. TAGRISSO is a prescription drug approved for the treatment of EGFR+ NSCLC to help prevent your lung cancer from coming back after surgery.

In a clinical trial TAGRISSO significantly lowered the chance of EGFR+ non-small cell lung cancer coming back after surgery

Following surgery, TAGRISSO may prevent EGFR+ non-small cell lung cancer from returning

In a clinical trial stage 2 and 3A EGFR+ NSCLC patients treated with TAGRISSO after surgery were 83% less likely to experience cancer recurrence or death than with placebo

In a clinical study, Stage 2 and 3A patients treated with TAGRISSO following surgery were 83% less likely to experience cancer recurrence or death than with placebo.

In a clinical trial stage 1B, 2, and 3A EGFR+ NSCLC patients treated with TAGRISSO after surgery were 80% less likely to experience cancer recurrence or death than with placebo

In the same clinical study, Stage 1B, 2, and 3A patients treated with TAGRISSO following surgery were 80% less likely to experience cancer recurrence or death than with placebo.

How the trial worked

During the clinical study, 682 adults with stage 1B, 2, and 3A EGFR+ NSCLC who had undergone complete tumor removal and may have had subsequent chemotherapy were treated with either TAGRISSO® (osimertinib) or placebo. The treatment was given for up to 3 years or until disease recurrence or the patient stopped treatment.

The main goal of the trial was to measure the time people with stage 2 and 3A NSCLC were on treatment before their cancer came back or they died. This is called disease-free survival (DFS). A secondary goal was to measure DFS for all the people in the trial—stages 1B, 2 and 3A. In both cases, TAGRISSO significantly lowered the chance of EGFR+ non-small cell lung cancer coming back after surgery or death vs placebo.

How TAGRISSO treatment may help
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Tagrisso is a pill that you take once a day, with or without food

TAGRISSO is a once-daily pill that you may be able to take at home, with or without food.

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Cancer that started in the lungs and has spread to other parts of the body such as the liver or brain. Often referred to as stage 4 cancer.

One of two main types of lung cancer. NSCLC is more common.

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.

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

The middle number in a group of numbers arranged from lowest to highest.

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.

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

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

For a person living with cancer, the length of time during or after treatment in which cancer does not get worse.

The amount of time people were on initial treatment before their cancer came back or they died.

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.

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