Drug updated on 4/16/2024
| Dosage Form | Tablet (oral: 250 mg) |
| Drug Class | Isocitrate 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
- Ivosidenib (Tibsovo) is indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test, in various conditions including newly diagnosed Acute Myeloid Leukemia (AML), relapsed or refractory AML and Myelodysplastic Syndromes (MDS), and locally advanced or metastatic Cholangiocarcinoma.
- The drug has been used both as monotherapy and in combination with azacitidine, particularly for the treatment of newly diagnosed AML in adults 75 years or older, or those who have comorbidities that preclude use of intensive induction chemotherapy.
- In treating newly diagnosed IDH-mutated AML patients, ivosidenib showed a complete response rate of 47%, overall response rate of 65%, two-year survival rate at 45% and event-free survival at 29%. However, it may not be optimal due to low complete response rates compared to other treatments.
- For relapsed/refractory IDH-mutated AML patients treated with ivosidenib, the results were lower: complete response was seen in only about one-fifth of cases while median overall survival was just over eight months; gastrointestinal adverse events were most common among all-grade adverse events reported during trials.
- When combined with hypomethylating agents like venetoclax/ivosidenib yielded better hazard ratios for overall survival (0.44-0.66) and event-free survival (0.33-0.63) than other agents; however this combination also led to more frequent adverse events except when paired specifically with azacitidine.
- The information provided is based on three systematic reviews/meta-analyses which included clinical trials data from multiple sources such as PubMed, Embase etc., providing comprehensive insights into the efficacy and safety profile of Tibsovo in treating various conditions.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Tibsovo (ivosidenib) Prescribing Information. | 2022 | Servier Pharmaceuticals LLC, Boston, MA |