Ivosidenib

(Tibsovo®)

Tibsovo®

Drug updated on 5/17/2024

Dosage FormTablet (oral; 250 mg)
Drug ClassIsocitrate dehydrogenase-1 inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for 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.
  • Indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with Relapsed or refractory AML for the treatment of adult patients with relapsed or refractory AML.
  • Indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with relapsed or refractory Myelodysplastic Syndromes (MDS) for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes.
  • Indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with Locally Advanced or Metastatic Cholangiocarcinoma for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated.

Summary
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  • Ivosidenib (Tibsovo) is indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test. It is used in treating newly diagnosed Acute Myeloid Leukemia (AML), relapsed or refractory AML, myelodysplastic syndromes, and locally advanced or metastatic cholangiocarcinoma.
  • Four systematic reviews/meta-analyses provided insights into Tibsovo's safety and effectiveness across its various indications.
  • In terms of effectiveness for newly diagnosed AML patients with IDH mutations, Tibsovo demonstrated a complete response rate of 47% when used alone but showed improved survival outcomes when combined with azacitidine.
  • For relapsed or refractory AML cases, the complete response rate was lower at 21%, indicating that Tibsovo may not be optimal as monotherapy due to low CR rates in this population group; however, it still represents a promising option.
  • Compared to other existing targeted therapies such as azacitidine monotherapy, combining Tibsovo with hypomethylating agents like azacitidine yielded better overall survival hazard ratios, suggesting superior effectiveness especially among those ineligible for first-line induction chemotherapy.
  • The most frequently occurring adverse events associated with using Ivosidenib are gastrointestinal issues and hematologic adverse events. However, these side effects appear manageable, particularly when administered alongside azacitidine, which has shown comparatively lower infection rates.