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.

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