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Tibsovo FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 1, 2021.

FDA Approved: Yes (First approved July 20, 2018)
Brand name: Tibsovo
Generic name: ivosidenib
Dosage form: Tablets
Company: Servier Pharmaceuticals
Treatment for: Acute Myeloid Leukemia, Cholangiocarcinoma of Biliary Tract

Tibsovo (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor used in the treatment of patients with IDH1-mutated acute myeloid leukemia (AML) and IDH1-mutated cholangiocarcinoma.

  • Tibsovo is indicated for the treatment of adult patients with a susceptible IDH1 mutation as detected by an FDA-approved test with:
    • Acute Myeloid Leukemia (AML)
      • Newly-diagnosed AML who are ≥ 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy
      • Relapsed or refractory AML
    • Locally Advanced or Metastatic Cholangiocarcinoma
      • Locally advanced or metastatic cholangiocarcinoma who have been previously treated.
  • Tibsovo is an isocitrate dehydrogenase-1 inhibitor that works by decreasing abnormal production of the oncometabolite 2-hydroxyglutarate (2-HG), leading to differentiation of malignant cells.
  • Tibsovo tablets are taken orally once daily with or without food, until disease progression or unacceptable toxicity.
  • Tibsovo can cause serious adverse reactions including QTc interval prolongation and Guillain-Barré syndrome. The Tibsovo product label carries a boxed warning for differentiation syndrome in AML patients.
  • Common adverse reactions in patients with AML include fatigue, arthralgia, leukocytosis, diarrhea, edema, nausea, dyspnea, mucositis, electrocardiogram QT prolonged, rash, cough, decreased appetite, myalgia, constipation, pyrexia, and laboratory abnormalities. Common adverse reactions in patients with cholangiocarcinoma include fatigue, nausea, abdominal pain, diarrhea, cough, decreased appetite, ascites, vomiting, anemia, rash, and laboratory abnormalities.

Development Timeline for Tibsovo

Aug 25, 2021Approval  Servier Announces FDA Approval of Tibsovo (ivosidenib tablets) in IDH1-Mutated Cholangiocarcinoma
May  2, 2019Approval  Agios Announces FDA Approval of Tibsovo as Monotherapy for Newly Diagnosed Adult Patients with IDH1 Mutant Acute Myeloid Leukemia (AML) Not Eligible for Intensive Chemotherapy
Jul 20, 2018Approval  FDA Approves Tibsovo (ivosidenib) for Relapsed or Refractory Acute Myeloid Leukemia with an IDH1 Mutation
Feb 15, 2018FDA Accepts New Drug Application and Grants Priority Review for Ivosidenib in Relapsed or Refractory AML with an IDH1 Mutation
Dec 26, 2017Agios Submits New Drug Application to the FDA for Ivosidenib for the Treatment of Patients with Relapsed/Refractory AML and an IDH1 Mutation

Further information

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