Regulatory approval

Published by the Health Canada.

Health Canada approved vorasidenib for the treatment of Grade 2a astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation or isocitrate dehydrogenase-2 (IDH2) mutation in adults and pediatric patients aged 12 years and older following surgical intervention.

This is written in the approval document as:

VORANIGO (vorasidenib tablets) is indicated for the treatment of Grade 2a astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation or isocitrate dehydrogenase-2 (IDH2) mutation in adults and pediatric patients aged 12 years and older following surgical intervention.

Citation

Servier Canada Inc. Voranigo (vorasidenib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00076841.PDF. Published August 2024. Accessed June 2025.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) IDH1 p.R132C Astrocytoma Vorasidenib
Sensitivity (+) IDH1 p.R132G Astrocytoma Vorasidenib
Sensitivity (+) IDH1 p.R132H Astrocytoma Vorasidenib
Sensitivity (+) IDH1 p.R132L Astrocytoma Vorasidenib
Sensitivity (+) IDH1 p.R132S Astrocytoma Vorasidenib
Sensitivity (+) IDH2 p.R172K Astrocytoma Vorasidenib
Sensitivity (+) IDH2 p.R172M Astrocytoma Vorasidenib
Sensitivity (+) IDH2 p.R172G Astrocytoma Vorasidenib
Sensitivity (+) IDH2 p.R172S Astrocytoma Vorasidenib
Sensitivity (+) IDH2 p.R172W Astrocytoma Vorasidenib
Sensitivity (+) IDH1 p.R132C Oligodendroglioma Vorasidenib
Sensitivity (+) IDH1 p.R132G Oligodendroglioma Vorasidenib
Sensitivity (+) IDH1 p.R132H Oligodendroglioma Vorasidenib
Sensitivity (+) IDH1 p.R132L Oligodendroglioma Vorasidenib
Sensitivity (+) IDH1 p.R132S Oligodendroglioma Vorasidenib
Sensitivity (+) IDH2 p.R172K Oligodendroglioma Vorasidenib
Sensitivity (+) IDH2 p.R172M Oligodendroglioma Vorasidenib
Sensitivity (+) IDH2 p.R172G Oligodendroglioma Vorasidenib
Sensitivity (+) IDH2 p.R172S Oligodendroglioma Vorasidenib
Sensitivity (+) IDH2 p.R172W Oligodendroglioma Vorasidenib