Tibsovo (ivosidenib)
An approved treatment for Cholangiocarcinoma.
The same compound appears under different names depending on the context. Here is how to identify Ivosidenib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Ivosidenib
- Brand name
- Tibsovo
- Development code
- AG-120
- Drug class
- Targeted small molecule (IDH1 inhibitor)
- Manufacturer
- Servier
- How it's taken
- Ivosidenib is taken by mouth at 500 mg (2 tablets of 250 mg) once daily, with or without food, but not with a high-fat meal, until the cancer grows or side effects become too hard to manage.
A daily pill for adults with previously treated, locally advanced or metastatic cholangiocarcinoma whose tumors carry an IDH1 mutation (about 15% of cases), confirmed by an FDA-approved test. It blocks the mutant enzyme that drives tumor growth in these specific cancers.
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Where Ivosidenib fits
First targeted therapy for IDH1-mutated cholangiocarcinoma, used in previously treated patients. Requires tumor genomic testing to confirm IDH1 mutation before treatment.
How Ivosidenib works
Ivosidenib blocks mutant IDH1, an enzyme that is abnormally active in certain cholangiocarcinoma tumors. When IDH1 is mutated, it produces a molecule called 2-HG that drives cancer growth. Ivosidenib reduces 2-HG levels, allowing cancer cells to mature normally and stop growing uncontrollably.
Mechanism: Inhibits mutant isocitrate dehydrogenase 1 (IDH1) enzyme
Side effects and safety
Common side effects include fatigue, nausea, diarrhea, abdominal pain, and decreased appetite. Other common side effects in cholangiocarcinoma include cough, fluid in the belly (ascites), vomiting, low red blood cell counts (anemia), and rash. Ivosidenib can change heart rhythm (QTc prolongation), so your doctor will check ECGs, and it can rarely cause Guillain-Barre syndrome, a nerve disorder that causes weakness or numbness. The boxed warning for differentiation syndrome applies to people treated for blood cancers (AML and MDS), not cholangiocarcinoma.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Ivosidenib
Ivosidenib is taken by mouth at 500 mg (2 tablets of 250 mg) once daily, with or without food, but not with a high-fat meal, until the cancer grows or side effects become too hard to manage. It can be taken at home on a regular daily schedule.
Availability and cost
Only available as the brand-name product.
First-in-class targeted therapy for IDH1-mutated cancers. Precision oncology drug serving a molecularly defined subset of an already rare cancer type.
Help paying for Tibsovo
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Commercial co-pay program lowers out-of-pocket costs for commercially insured patients; no income restrictions. Government insurance not eligible.
For: private insurance · source - Free medicine program
Patient Assistance Program may provide Tibsovo to uninsured or underinsured patients; income requirements apply.
For: no insurance, underinsured · source - Bridge or quick-start supply
Patients waiting for insurance coverage may be eligible for a free product program; contact ServierONE.
The official page does not say who qualifies. Ask the program. · source - Insurance and case manager help
ServierONE works with patients, caregivers and doctors on getting treatment started and can refer government-insured patients to independent foundations.
The official page does not say who qualifies. Ask the program. · source
Good to know: Copay enrollment is at servierone-copay.com. Servier customer service is 1-800-807-6124. servierone.com did not load in this check; program details confirmed on tibsovo.com.
- From a charity · The Assistance FundBiliary Tract Cancer fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “WAITLIST — Accepting Waitlist Patients. TAF is currently accepting requests to join the enrollment waitlist for this program. Waitlists a…”
Clinical trial results
In the Phase 3 ClarIDHy trial of 185 patients with IDH1-mutated cholangiocarcinoma, ivosidenib significantly improved progression-free survival. FDA approved it on August 25, 2021, making it the first drug specifically for IDH1-mutated cholangiocarcinoma.
Development history
Ivosidenib (AG-120) was developed by Agios Pharmaceuticals as the first-in-class IDH1 inhibitor. The company discovered that IDH1 mutations are particularly common in cholangiocarcinoma, making this a targeted approach for a subset of patients.
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Common questions about Ivosidenib
▸What is Ivosidenib (Tibsovo)?
A daily pill for adults with previously treated, locally advanced or metastatic cholangiocarcinoma whose tumors carry an IDH1 mutation (about 15% of cases), confirmed by an FDA-approved test. It blocks the mutant enzyme that drives tumor growth in these specific cancers.
▸How does Ivosidenib work?
Ivosidenib blocks mutant IDH1, an enzyme that is abnormally active in certain cholangiocarcinoma tumors. When IDH1 is mutated, it produces a molecule called 2-HG that drives cancer growth. Ivosidenib reduces 2-HG levels, allowing cancer cells to mature normally and stop growing uncontrollably.
▸What are the side effects of Ivosidenib?
Common side effects include fatigue, nausea, diarrhea, abdominal pain, and decreased appetite. Other common side effects in cholangiocarcinoma include cough, fluid in the belly (ascites), vomiting, low red blood cell counts (anemia), and rash. Ivosidenib can change heart rhythm (QTc prolongation), so your doctor will check ECGs, and it can rarely cause Guillain-Barre syndrome, a nerve disorder that causes weakness or numbness. The boxed warning for differentiation syndrome applies to people treated for blood cancers (AML and MDS), not cholangiocarcinoma.
▸How is Ivosidenib taken?
Ivosidenib is taken by mouth at 500 mg (2 tablets of 250 mg) once daily, with or without food, but not with a high-fat meal, until the cancer grows or side effects become too hard to manage. It can be taken at home on a regular daily schedule.
▸Is Ivosidenib FDA approved?
Yes, Ivosidenib (Tibsovo) is FDA approved (2018) for the treatment of Cholangiocarcinoma.
▸What is an IDH1 mutation and who has it?
IDH1 (isocitrate dehydrogenase 1) is an enzyme that when mutated produces an abnormal metabolite (2-HG) that drives cancer growth. About 15% of cholangiocarcinoma patients have IDH1 mutations, making ivosidenib a precision medicine for this specific subset.
▸How is IDH1 mutation testing done?
IDH1 mutation status is determined through tumor genomic testing, typically using next-generation sequencing on a biopsy sample. Testing must confirm the mutation before ivosidenib can be prescribed, as the drug only works in IDH1-mutated cancers.
▸What is differentiation syndrome?
Differentiation syndrome is a serious reaction that has occurred in people taking ivosidenib for blood cancers (AML and MDS), usually in the first 3 months, causing fever, low blood pressure, and breathing problems. It happens when leukemia cells suddenly mature (differentiate). The label's boxed warning covers AML and MDS only; it is not listed as a risk for cholangiocarcinoma, where the main label warnings are heart rhythm changes and Guillain-Barre syndrome.
▸What did the ClarIDHy trial demonstrate?
The ClarIDHy trial of 185 patients with IDH1-mutated cholangiocarcinoma showed ivosidenib significantly improved progression-free survival. It became the first drug specifically approved for IDH1-mutated cholangiocarcinoma in August 2021.
▸How is ivosidenib taken?
Ivosidenib is taken by mouth at 500 mg (2 tablets of 250 mg) once daily, with or without food, but not with a high-fat meal, until the cancer grows or side effects become too hard to manage. The oral formulation allows convenient at-home treatment.
▸Who originally developed ivosidenib?
Ivosidenib (AG-120) was developed by Agios Pharmaceuticals as the first-in-class IDH1 inhibitor. It is now marketed by Servier under the brand name Tibsovo.