Drug updated on 12/11/2024
| Dosage Form | Tablet (oral; 10 mg, 40 mg) |
| Drug Class | Isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection
Latest News
Summary
- This summary is based on the review of one randomized controlled trial. [1]
- Progression-Free Survival (PFS): Vorasidenib demonstrated a median PFS of 27.7 months versus 11.1 months with placebo, with a hazard ratio for disease progression or death of 0.39 (95%confidence interval (CI), 0.27 to 0.56; P<0.001) favoring vorasidenib.
- Time to Next Anticancer Intervention: Vorasidenib significantly extended the time to the next anticancer intervention compared to placebo, with a hazard ratio of 0.26 (95% CI, 0.15 to 0.43; P<0.001).
- Adverse events of grade 3 or higher were reported in 22.8% of patients receiving vorasidenib and 13.5% of those receiving placebo. An increased alanine aminotransferase (ALT) level of grade 3 or higher occurred in 9.6% of patients receiving vorasidenib and in no patients receiving placebo.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Voranigo (vorasidenib) Prescribing Information. | 2024 | Servier Pharmaceuticals LLC, Boston, MA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma | 168Subjects F: 40% M: 60% | 2023 | The New England Journal Of Medicine |
Document Title
Sex Distribution:
F:40%
M:60%
168Subjects
Year:
2023
Source:The New England Journal Of Medicine
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| SEOM-GEINO clinical guidelines for grade 2 gliomas (2023) | 2024 | Clinical and Translational Oncology |