Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration (FDA) has granted approval to vorasidenib 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.

This is written in the approval document as:

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.

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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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (2) IDH1 p.R132C Astrocytoma Vorasidenib
FDA (2) IDH1 p.R132G Astrocytoma Vorasidenib
FDA (2) IDH1 p.R132H Astrocytoma Vorasidenib
FDA (2) IDH1 p.R132L Astrocytoma Vorasidenib
FDA (2) IDH1 p.R132S Astrocytoma Vorasidenib
FDA (2) IDH2 p.R172K Astrocytoma Vorasidenib
FDA (2) IDH2 p.R172M Astrocytoma Vorasidenib
FDA (2) IDH2 p.R172G Astrocytoma Vorasidenib
FDA (2) IDH2 p.R172S Astrocytoma Vorasidenib
FDA (2) IDH2 p.R172W Astrocytoma Vorasidenib
FDA (2) IDH1 p.R132C Oligodendroglioma Vorasidenib
FDA (2) IDH1 p.R132G Oligodendroglioma Vorasidenib
FDA (2) IDH1 p.R132H Oligodendroglioma Vorasidenib
FDA (2) IDH1 p.R132L Oligodendroglioma Vorasidenib
FDA (2) IDH1 p.R132S Oligodendroglioma Vorasidenib
FDA (2) IDH2 p.R172K Oligodendroglioma Vorasidenib
FDA (2) IDH2 p.R172M Oligodendroglioma Vorasidenib
FDA (2) IDH2 p.R172G Oligodendroglioma Vorasidenib
FDA (2) IDH2 p.R172S Oligodendroglioma Vorasidenib
FDA (2) IDH2 p.R172W Oligodendroglioma Vorasidenib

Contributions

Date Contributor Description
2024-10-30 Van Allen lab Initial access of FDA approvals
2024-08-06 Food and Drug Administration Indication received traditional approval.