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Tibsovo FDA Approval History

Last updated by Judith Stewart, BPharm on May 31, 2022.

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

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

  • Tibsovo is indicated for the treatment of adult patients with a susceptible IDH1 mutation as detected by an FDA-approved test with:
    - Newly Diagnosed Acute Myeloid Leukemia (AML)
    In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
    - Relapsed or Refractory AML
    For the treatment of adult patients with relapsed or refractory AML
    - Relapsed or Refractory Myelodysplastic Syndromes (MDS)
    For the treatment of adult patients with relapsed or refractory myelodysplastic syndromes
    - Locally Advanced or Metastatic Cholangiocarcinoma
    For the treatment of adult patients with 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

DateArticle
Oct 24, 2023Approval Servier Announces FDA Approval of Tibsovo (ivosidenib tablets) for the Treatment of IDH1-Mutated Relapsed or Refractory (R/R) Myelodysplastic Syndromes (MDS)
May 25, 2022Approval Servier Announces FDA Approval of Tibsovo (ivosidenib tablets) in Combination with Azacitidine for Patients with Newly Diagnosed IDH1-mutated Acute Myeloid Leukemia
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

See also

Tibsovo (ivosidenib) Consumer information

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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