Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 10 mg, 40 mg) |
Drug Class | Isocitrate dehydrogenase-1 (IDH1) inhibitors 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
- Voranigo (Vorasidenib) is 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, subtotal resection, or gross total resection.
- This summary is based on the review of one randomized controlled trial(s). [1]
- Vorasidenib, an IDH inhibitor, has demonstrated significant efficacy in treating grade 2 gliomas in patients who have not previously undergone radiotherapy (RT) or chemotherapy (CT), suggesting it may be an effective treatment option for this population.
- No direct comparative effectiveness data is provided between vorasidenib and other treatment modalities such as surgery, RT, or CT within the same study.
- The studies do not detail differences in effectiveness among various population types or subgroups, limiting conclusions on subgroup-specific efficacy.
- There is no safety information available in the reviewed studies.
- The studies focus on adult patients with grade 2 gliomas, particularly oligodendrogliomas and astrocytomas with IDH mutations, and highlight the significant efficacy of IDH inhibitors like vorasidenib in these tumors not previously treated with RT or CT; no additional subgroup-specific findings are available.
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: 60% M: 40% | 2023 | The New England Journal of Medicine |
Document Title
Sex Distribution:
F:60%
M:40%
168Subjects
Year:
2023
Source:The New England Journal of Medicine
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
NCCN Clinical Practice Guidelines in Oncology. Central Nervous System Cancers, Version 2.2024. | 2024 | National Comprehensive Cancer Network |
SEOM-GEINO clinical guidelines for grade 2 gliomas (2023). | 2024 | Clinical and Translational Oncology |