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TIBSOVO clinical trial

TIBSOVO TRIAL RESULTS IN
CHOLANGIOCARCINOMA (CCA)

TIBSOVO was studied in a clinical trial involving 185 adult patients with an IDH1 mutation whose disease had progressed after previous
treatments. The purpose of the trial was to determine how long patients who received TIBSOVO lived without their CCA getting worse.

The trial studied patients who:

  • Had their cancer get worse after receiving at least 1 but not more than 2 previous treatments
  • Had disease that spread
  • Had an IDH1 mutation

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

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Benefits of TIBSOVO

BENEFITS OF TIBSOVO

In the trial, TIBSOVO helped to slow the progression of CCA

People treated with TIBSOVO achieved better control of their CCA vs. people who received placebo

One year.

Patients treated with TIBSOVO were less likely to experience disease progression or die during the first year of treatment

More than half of the patients who took TIBSOVO achieved stable disease, which means their CCA did not continue to spread, vs. 28% of patients who received placebo

51 percent TIBSOVO.
28 percent placebo.

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

Taking TIBSOVO and possible side effects
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References: 1. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2023. 2. Zhu AX, Macarulla T, Javle MM, et al. Final results from ClarIDHy, a global, phase 3, randomized, double-blind study of ivosidenib versus placebo in patients with previously treated cholangiocarcinoma and an isocitrate dehydrogenase 1 (IDH1) mutation. Presented at: ASCO Gastrointestinal Cancers Symposium; January 15-17, 2021. 3. Frampton JE. Ivosidenib: a review in advanced cholangiocarcinoma. Target Oncol. 2023;18(6):973-980. doi:10.1007/s11523-023-01002-3
 

What is TIBSOVO?

TIBSOVO is a prescription medicine used to treat adults with an isocitrate dehydrogenase-1 (IDH1) mutation with bile duct cancer (cholangiocarcinoma) that has spread and who have already received previous treatment(s).

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) before and during treatment with TIBSOVO. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint
  • 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 of the possible side effects of TIBSOVO. Call your doctor for medical advice about side effects. You may report side effects to 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 healthcare provider 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.

Last update: September 2026

Information on this website is reviewed through established medical, legal, and regulatory processes to support accurate, balanced, and label-consistent communication about TIBSOVO.

 

What is TIBSOVO?

TIBSOVO is a prescription medicine used to treat adults with an isocitrate dehydrogenase-1 (IDH1) mutation with bile duct cancer (cholangiocarcinoma) that has spread and who have already received previous treatment(s).

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) before and during treatment with TIBSOVO. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint

IMPORTANT SAFETY INFORMATION