Voranigo (vorasidenib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Servier Pharmaceuticals LLC. Voranigo (vorasidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf. Revised August 2024. Accessed October 30, 2024.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
VORANIGO is 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. 20

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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