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Updated: Jun 11, 2025

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Vorasidenib: First Approval.

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  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

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Summary
This summary is machine-generated.

Vorasidenib is a new brain-penetrant drug approved for IDH-mutant glioma. It significantly improved progression-free survival in patients with grade 2 astrocytoma or oligodendroglioma.

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Area of Science:

  • Oncology
  • Neuro-oncology
  • Pharmacology

Background:

  • Diffuse gliomas often harbor mutations in isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes.
  • Targeting these mutant enzymes represents a novel therapeutic strategy for IDH-mutant gliomas.

Purpose of the Study:

  • To summarize the development milestones of vorasidenib, a first-in-class IDH1/2 inhibitor.
  • To highlight the recent US FDA approval for vorasidenib in IDH-mutant grade 2 glioma.

Main Methods:

  • Vorasidenib is an orally administered, brain-penetrant dual inhibitor of mutant IDH1/2 enzymes.
  • Phase III INDIGO trial evaluated vorasidenib versus placebo in patients with IDH-mutant diffuse glioma.

Main Results:

  • Vorasidenib demonstrated a significant improvement in progression-free survival compared to placebo.
  • Time to the next anticancer intervention was also significantly improved with vorasidenib.

Conclusions:

  • Vorasidenib is the first approved therapy targeting IDH-mutant diffuse glioma.
  • Regulatory reviews are ongoing in the EU and other regions for this targeted therapy.