About CHOLANGIOCARCINOMA (CCA)

What is cholangiocarcinoma?

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Digestive system diagram showing the bile duct.

CholangiocarcinomaCholangiocarcinoma, also called bile duct cancer, is a rare cancer that forms in the bile ducts., also called Bile ducts are tubes that carry bile (fluid made by the liver) between the liver and gallbladder and the small intestine.bile duct cancer, is a rare and aggressive cancer that forms in the bile ducts inside and around the liver. It accounts for about 3% of cancers in the gastrointestinal systemGastrointestinal system includes the mouth, throat, esophagus, stomach, small intestine, large intestine, rectum, and anus. It also includes the salivary glands, liver, gallbladder, and pancreas, which help the body digest food and liquids. Also called the digestive system..

Approximately 8000 people in the United States are diagnosed with cholangiocarcinoma each year, but because it is a difficult cancer to diagnose, the actual number of cases may be higher.

Signs and symptoms of cholangiocarcinoma are not specific, and many cases are not diagnosed until the disease has progressed when surgery may no longer be an option. The recommended treatment will depend on whether or not the tumor has advanced or metastasizedAdvanced cholangiocarcinoma means there are several tumors in the bile ducts. Metastatic cholangiocarcinoma means the cancer has spread to other places in the body, such as nearby tissue, lymph nodes, or more distant parts of the body..

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Digestive system diagram showing the bile duct.

Types of cholangiocarcinoma

According to the site of origin:

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  • Intrahepatic cholangiocarcinoma means the tumor originates in the bile ducts inside the liver
  • Extrahepatic cholangiocarcinoma means the tumor originates in the bile ducts outside of the liver

According to the tumor location:

  • If the tumor stays in the place it first formed, it is called localized disease
  • If there are several tumors in the bile ducts or if the cancer has spread to other parts of the body, it is called advanced or metastatic disease. If it has spread to other places in the body, such as a lung, it is still considered to be cholangiocarcinoma

Genetic mutations in cholangiocarcinoma

Cholangiocarcinoma can develop because of certain genetic abnormalities, or mutationsMutations are changes in the DNA sequences of cells. Mutations may be caused by mistakes during cell division, or they may be caused by exposure to DNA-damaging agents in the environment. Certain mutations may lead to cancer or other diseases.. Genetic mutations are changes in the DNA of a cell. They can result in cells growing and dividing without the usual controls. Over time, a mass of uncontrolled cells can grow and become a tumor.

Biomarker testing
Your doctor may recommend biomarker testingBiomarker testing involves a piece of tumor (from biopsy or surgery) being sent to the laboratory for analysis to check for certain genes, proteins, or other molecules that may be a sign of a disease or condition, such as cancer. to look for specific changes in the DNA of the cancer cells.

Biomarker testing involves a piece of your tumor (obtained from biopsy or surgery) being sent to the laboratory for analysis.

It may take a few weeks to get results, but the results will enable your doctor to personalize the best approach to treating your type of cancer.

HOW TREATMENT WITH TIBSOVO WORKS

Targeting IDH1 mutations in cholangiocarcinoma

The first treatment of its kind, TIBSOVO is a targeted therapyTargeted therapy is a type of treatment that can block the action of certain molecules involved in the growth and spread of cancer cells with less harm to normal cells. that works against the IDH1IDH1 stands for isocitrate dehydrogenase-1. In healthy cells, IDH1 plays an important role in normal chemical reactions. When IDH1 is altered due to a genetic mutation, it may promote the development of certain types of cancers, including cholangiocarcinoma. mutation. IDH1 stands for isocitrate dehydrogenase-1. In healthy cells, the IDH1 gene makes the IDH1 protein, which plays a role in normal chemical reactions within cells. When the IDH1 gene is altered due to a genetic mutation, cells make an abnormal (mutated) version of the IDH1 protein. This mutated IDH1 protein may promote the development of certain types of cancers, including cholangiocarcinoma.

Up to 20% of intrahepatic cholangiocarcinomaIntrahepatic cholangiocarcinoma means the tumor originates in the bile ducts inside the liver. cases have an IDH1 mutation. That's why biomarker testing for mutations can help your healthcare team understand if TIBSOVO is right for you.

How TIBSOVO works against your cholangiocarcinoma

Targeted Therapy
TIBSOVO specifically targets the mutated IDH1 protein, which can slow down the progression of advanced cholangiocarcinoma.

TIBSOVO works differently from traditional chemotherapyChemotherapy is a drug treatment that uses chemicals to kill cells that divide quickly, including cancer cells and cells in healthy tissue.. Chemotherapy kills cells that divide quickly, including both tumor cells and cells in healthy tissue. Chemotherapy is also typically given by infusionInfusion therapy is when medication or fluids are administered through a needle or catheter. Also called intravenous infusion, it's a way of delivering medication that can't be taken orally or that needs to be dispensed at a controlled pace., which usually takes place in an infusion center.

Proven results
For patients with advanced mutated IDH1 cholangiocarcinoma who have been previously treated, targeted therapy with TIBSOVO has been shown to increase the length of time a person can live with cholangiocarcinoma without the disease getting worse.

Convenient once-daily pill
TIBSOVO is a pill that's typically prescribed for patients to take 2 tablets once a day. You can take TIBSOVO at home with or without food and without the infusion time requirements of chemotherapy.

Traditional chemotherapy is cytotoxicCytotoxic means toxic to living cells, “cyto” means cell and “toxic” means poison, as in chemotherapy drugs that kill cancer cells., which means it kills both abnormal and healthy cells. Unlike chemotherapy, TIBSOVO only targets tumor cells with mutated IDH1.

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What is TIBSOVO?

TIBSOVO is a prescription medicine used to treat adults with bile duct cancer (cholangiocarcinoma) that has spread:

  • who have already received previous treatment(s) and
  • whose tumor has a certain type of abnormal isocitrate dehydrogenase-1 (IDH1) mutation

Your healthcare provider will perform a test to make sure that TIBSOVO is right for you. It is not known if TIBSOVO is safe and effective in children.

 

IMPORTANT SAFETY INFORMATION

TIBSOVO may cause serious side effects, including:

  • Changes in the electrical activity of your heart called QTc prolongation. QTc prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) during treatment with TIBSOVO. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint.
  • Guillain-Barré Syndrome. Guillain-Barré syndrome has happened in people treated with TIBSOVO. Your healthcare provider will monitor you for nervous system problems and will permanently stop your treatment with TIBSOVO if you develop Guillain-Barré syndrome. Tell your healthcare provider right away if you develop any signs or symptoms of Guillain-Barré syndrome, including:
  • weakness or tingling feeling in your legs, arms, or upper body
  • numbness and pain on one side or both sides of your body
  • any changes in your ability to see, touch, hear, or taste
  • burning or prickling sensation
  • difficulty breathing

The most common side effects of TIBSOVO in adults with Cholangiocarcinoma include:

  • fatigue
  • nausea
  • abdominal pain
  • diarrhea
  • cough
  • decreased appetite
  • fluid and swelling in your stomach area
  • vomiting
  • hemoglobin decreased (anemia)
  • rash
  • changes in liver function tests

Your healthcare provider will do blood tests before you start and during treatment with TIBSOVO. Your healthcare provider may decrease, temporarily hold, or permanently stop your treatment with TIBSOVO if you develop certain side effects.

TIBSOVO may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of TIBSOVO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

  • have any heart problems, including a condition called long QT syndrome
  • have problems with abnormal electrolytes, such as sodium, potassium, calcium, or magnesium levels
  • have nervous system problems
  • have problems with your kidneys or are on dialysis
  • have any liver disorders, including cirrhosis
  • are pregnant or plan to become pregnant. TIBSOVO can cause harm to your unborn baby. You should avoid becoming pregnant during treatment with TIBSOVO. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with TIBSOVO
  • are breastfeeding or plan to breastfeed. It is not known if TIBSOVO passes into your breast milk. Do not breastfeed during your treatment with TIBSOVO and for 1 month after your last dose of TIBSOVO

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take hormonal contraceptives. TIBSOVO may affect how hormonal contraceptives work and may cause them to not work as well.

Please see Full Prescribing Information, including Medication Guide.

 

What is TIBSOVO?

TIBSOVO is a prescription medicine used to treat adults with bile duct cancer (cholangiocarcinoma) that has spread:

  • who have already received previous treatment(s) and
  • whose tumor has a certain type of abnormal isocitrate dehydrogenase-1 (IDH1) mutation

IMPORTANT SAFETY INFORMATION

TIBSOVO may cause serious side effects, including:

  • Changes in the electrical activity of your heart called QTc prolongation. QTc prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) during treatment with TIBSOVO. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint.

IMPORTANT SAFETY INFORMATION