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Association details:
| Biomarker: | IDH2 mutation |
|---|---|
| Cancer: | Oligodendroglioma |
| Drug: | Voranigo (vorasidenib) (IDH1 inhibitor, IDH2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Servier's VORANIGO® (vorasidenib) Tablets Receives FDA Approval as First Targeted Therapy for Grade 2 IDH-mutant Glioma
Published date:
08/06/2024
Excerpt:
Servier...FDA) has approved VORANIGO®, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, 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.
Source:
Title:
INDIGO: A global, randomized, double-blinded, phase 3 study of vorasidenib versus placebo in patients with residual or recurrent grade 2 glioma with an IDH1/2 mutation.
Published date:
05/25/2023
Excerpt:
Of the 331 pts: median age: 40.4 years (range, 16 to 71); KPS =100: 53.5%; histological subtype: oligodendroglioma: 172 and astrocytoma: 159...This is the first prospective, randomized phase 3 study of a targeted therapy in grade 2 mIDH glioma. VOR significantly improved PFS by BIRC compared with PBO with a manageable safety profile.
DOI:
10.1200/JCO.2023.41.17_suppl.LBA1
Trial ID:
Source:
Title:
Vorasidenib Expanded Access Program
Excerpt:
...- Have IDH-mutant oligodendroglioma or astrocytoma per WHO 2021 criteria, with the IDH1 or IDH2 gene mutation confirmed by tissue-based diagnosis....
Trial ID:
Source:
Title:
Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
Excerpt:
...- Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) gene mutation status disease by central laboratory testing during the Prescreening period and available 1p19q status by local testing (eg, fluorescence in situ hybridization [FISH], comparative genomic hybridization [CGH] array, sequencing) using an accredited laboratory....
Trial ID:
