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WHAT TAGRISSO MAY DO FOR YOU

RESULTS WITH TAGRISSO

 

What TAGRISSO may do for you

Your metastatic EGFR mutation-positive non-small cell lung cancer (NSCLC) may have changed in a way that TAGRISSO was designed to help treat.

If your metastatic EGFR+ lung cancer progresses after your first TKI therapy, it’s often due to another mutation called T790M. As many as 2 out of 3 people whose cancer progressed after their first TKI therapy had tumors that tested positive for the EGFR T790M mutation.

If your tumor tests positive for T790M, your doctor may prescribe TAGRISSO. TAGRISSO may help you live longer without your tumors growing or spreading compared with chemotherapy.* It's the only treatment that targets the EGFR T790M mutation.

Ask your doctor when to have your cancer tested for the EGFR T790M mutation. Download the conversation starter for important questions to ask about testing for T790M.

*In a clinical study, the median time that people lived without tumors growing or spreading was 10.1 months for TAGRISSO compared with 4.4 months for those receiving chemotherapy.

Clinical study results

TAGRISSO was tested in people who:

  • Had metastatic EGFR+ NSCLC that tested positive for T790M
  • Were previously on their first TKI and may have received chemotherapy

TAGRISSO increased the chance of living without tumors growing or spreading by 70% compared with chemotherapy

The median time that people lived without tumors growing or spreading was more than twice as long with TAGRISSO compared with chemotherapy. People taking TAGRISSO lived without tumors growing or spreading for a median of 10.1 months, compared with 4.4 months for those receiving chemotherapy.*

6 out of 10

More than

6 OUT OF 10

PEOPLE TAKING TAGRISSO HAD THEIR TUMORS SHRINK

compared with 3 out of 10 people receiving chemotherapy

Tumors in the Brain

46 people who had tumors spread to the brain before the study were evaluated to see how TAGRISSO affected their brain tumors:

57% of those taking TAGRISSO and 25% of those receiving chemotherapy saw their brain tumors shrink.

*In the clinical study, 279 people took TAGRISSO and 140 people received chemotherapy.

65% of people taking TAGRISSO compared with 29% of people receiving chemotherapy.

Ask your doctor when the right time is to test for T790M and if TAGRISSO may be right for you.

About clinical studies

Several clinical studies for TAGRISSO have been conducted and are still ongoing. People who participated in these studies continued to live after their results were reported. Data about how much longer they lived is not yet available.

When researchers want to find out how well a medicine or therapy works for an illness, they test it in clinical studies with people who have the condition. Clinical studies help determine:

  • If a medicine works as intended
  • If it has side effects, and how mild or severe they might be

TAGRISSO may cause serious side effects, including:

  • lung problems. TAGRISSO may cause lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor 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 doctor should check your heart function before you start taking TAGRISSO and during treatment as needed. Tell your doctor 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 doctor 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 doctor may send you to see an eye specialist (ophthalmologist) if you get eye problems with TAGRISSO

Before taking TAGRISSO, tell your doctor 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 doctor right away if you become pregnant during treatment with TAGRISSO or think you may be pregnant.

    • Females who are able to become pregnant 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 doctor about the best way to feed your baby during this time

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

The most common side effects of TAGRISSO are:

  • diarrhea

  • rash

  • dry skin

  • changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from nailbed, and shedding of nails

  • tiredness

Tell your doctor 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 doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.1-800-FDA-1088.

What is TAGRISSO?

TAGRISSO is a prescription medicine used to treat non-small cell lung cancer... read more (NSCLC). TAGRISSO may be used when your non-small cell lung cancer has spread to other parts of the body and:

  • has a certain type of abnormal epidermal growth factor receptor (EGFR) gene, called T790M, and

  • you have had previous treatment with an EGFR tyrosine kinase inhibitor medicine and it has stopped working

Your doctor 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 accompanying full Prescribing Information including Patient Information.