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.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
HC (1) IDH1 p.R132C Astrocytoma Vorasidenib
HC (1) IDH1 p.R132G Astrocytoma Vorasidenib
HC (1) IDH1 p.R132H Astrocytoma Vorasidenib
HC (1) IDH1 p.R132L Astrocytoma Vorasidenib
HC (1) IDH1 p.R132S Astrocytoma Vorasidenib
HC (1) IDH2 p.R172K Astrocytoma Vorasidenib
HC (1) IDH2 p.R172M Astrocytoma Vorasidenib
HC (1) IDH2 p.R172G Astrocytoma Vorasidenib
HC (1) IDH2 p.R172S Astrocytoma Vorasidenib
HC (1) IDH2 p.R172W Astrocytoma Vorasidenib
HC (1) IDH1 p.R132C Oligodendroglioma Vorasidenib
HC (1) IDH1 p.R132G Oligodendroglioma Vorasidenib
HC (1) IDH1 p.R132H Oligodendroglioma Vorasidenib
HC (1) IDH1 p.R132L Oligodendroglioma Vorasidenib
HC (1) IDH1 p.R132S Oligodendroglioma Vorasidenib
HC (1) IDH2 p.R172K Oligodendroglioma Vorasidenib
HC (1) IDH2 p.R172M Oligodendroglioma Vorasidenib
HC (1) IDH2 p.R172G Oligodendroglioma Vorasidenib
HC (1) IDH2 p.R172S Oligodendroglioma Vorasidenib
HC (1) IDH2 p.R172W Oligodendroglioma Vorasidenib