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TIBSOVO RESULTS: CHOLANGIOCARCINOMA (CCA) CLINICAL TRIAL

The TIBSOVO clinical trial was designed to determine if once-daily TIBSOVO could reduce the risk of disease progression or death in patients with advanced cholangiocarcinomaAdvanced 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. with an 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 whose disease had progressed after previous treatments.

TIBSOVO was studied in a clinical trial involving 185 adult patients with cholangiocarcinoma who:

  • Had their cancer get worse after receiving at least 1 but not more than 2 previous treatment regimens
  • Had disease that had spread
  • Had a certain type of abnormal IDH1 mutation

The purpose of the trial was to determine how long patients lived without their cholangiocarcinoma getting worse.

TIBSOVO has been shown to increase the length of time a person can live with cholangiocarcinoma without it getting worse.

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Benefits of TIBSOVO

  • Patients treated with TIBSOVO achieved longer progression-free survivalProgression-free survival is the length of time during and after cancer treatment that a patient lives with the disease, but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well treatment works. Also called PFS. and better disease controlDisease control refers to the percentage of patients whose disease shrinks or remains stable over the study period in a clinical trial. compared with patients who received placebo
  • Patients taking TIBSOVO had a lower risk of disease progression over 6 to 12 months
  • More than half of the patients who took TIBSOVO achieved stable diseaseStable disease means neither an increase nor decrease in tumor size. vs 28% of patients who received placebo
results fpo image

Patients taking TIBSOVO had higher rates of stable disease than those who took placebo.

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Taking TIBSOVO and possible side effects
 
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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