Voranigo vorasidenib

Drug Class

Isocitrate dehydrogenase-1 and 2 (IDH1/2) inhibitor

Mechanism

Selectively inhibits mutated IDH1 and IDH2 enzymes, preventing the accumulation of the oncometabolite 2-hydroxyglutarate (2-HG) and restoring cellular differentiation.

Approved Indication

FDA-approved for adult and pediatric patients 12 years of age and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, following surgery.

What This Means For Patients

Voranigo is an oral IDH1/2 inhibitor for low-grade gliomas. Approved by the FDA, it is accessible for clinical use in Hainan Boao Lecheng ahead of mainland registration.

Regulatory Approvals

• FDA — approved (2024) — source

Pivotal Clinical Evidence

• INDIGO — Mellinghoff et al., N Engl J Med 2023 (NCT04164901) — DOI

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vorasidenib-grade-2-astrocytoma-or-oligodendroglioma-idh1-or-idh2-mutation
• https://www.servier.com/en/