Glossary

ALK

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.

Biomarker

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 NSCLC can include EGFR, ALK, PD-L1, BRAF, and ROS1. Testing for biomarkers is an important part of a complete lung cancer diagnosis.

BRAF

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.

Cancer

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.

Cancer cells

Abnormal cells that divide at a very fast rate and spread throughout the body, interfering with normal cells and normal cell activity.

Chemotherapy

Drug therapy that can kill cancer cells or stop them from dividing.

Dose

The amount of medicine you receive each time you take a treatment.

EGFR (epidermal growth factor receptor)

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 NSCLC biomarkers.

Immunotherapy

A type of biological therapy that uses substances to stimulate or suppress the immune system to help the body fight cancer, infection, and other diseases.

KRAS

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

Median

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

Metastatic (or advanced) lung cancer

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 IV cancer.

Mutation (gene mutation)

Any change in the DNA sequence of a cell. Mutations may be caused by mistakes during cell division or by exposure to DNA-damaging agents in the environment. They can be harmful, beneficial, or have no effect. Certain mutations may lead to cancer or other diseases.

NSCLC (non-small cell lung cancer)

One of two main types of lung cancer. NSCLC is the most common.

PD-L1

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.

Progression

When a therapy stops working and cancer cells grow or spread.

Protein

A molecule that plays a role in many of the processes that happen in cells, such as skin and hair growth.

Resistance

When cancer cells are no longer harmed by the drugs used to kill or disrupt them. Tumors can be resistant from the start of treatment or become resistant during the course of treatment.

ROS1

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.

Side effect

An unwanted reaction in the body after taking a treatment or therapy.

Stage

The measurement of cancer in the body. The stage is determined by the size of the tumor, whether cancer has entered the lymph nodes, and if the cancer has spread from where it started to other parts of the body.

Targeted therapy, targeted treatment

A cancer treatment that is designed to work specifically on the processes that cancer uses to grow rapidly and spread.

Tissue

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

TKI (tyrosine kinase inhibitor)

A substance that prevents enzymes called tyrosine kinases from working. These enzymes are involved in the growth and division of cells, including cancer cells. TKIs are a type of targeted therapy.

Tumor

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

T790M

A mutation that develops in EGFR+ NSCLC and causes the cancer to become resistant to the treatment being used (often a tyrosine kinase inhibitor or TKI).

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 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
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 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
  • mouth sores
  • tiredness
  • decreased appetite

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.

What is TAGRISSO?

TAGRISSO is a prescription medicine for non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic). TAGRISSO is used:

  • as a first treatment if tumors have a certain abnormal epidermal growth factor receptor (EGFR) gene(s)
  • or
  • for a certain type of EGFR gene that has been treated with an EGFR tyrosine kinase inhibitor (TKI) medicine that did not work or is no longer 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 full Prescribing Information including Patient Information.

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