FDA approved vorasidenib for IDH-mutant Grade 2 glioma in August 2024
The approval covers adult and pediatric patients 12 and older with Grade 2 astrocytoma or oligodendroglioma carrying a susceptible IDH1 or IDH2 mutation.
The Food and Drug Administration approved vorasidenib, marketed as Voranigo by Servier Pharmaceuticals LLC, on August 6, 2024. The drug is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor approved for adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma carrying a susceptible IDH1 or IDH2 mutation.1
The FDA's announcement provides the approval and indication details but does not include additional specifics such as trial data, dosing regimen, or safety findings in the posted record. Readers seeking those details are directed to the agency's fuller posting on the approval.
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