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
Further information
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