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FDA Approves Servier's Voranigo for Grade 2 Gliomas with IDH Mutations

Aug 6, 2024, 09:19 PM

The U.S. Food and Drug Administration (FDA) has approved Servier's vorasidenib, branded as Voranigo, for the treatment of Grade 2 gliomas with IDH1 or IDH2 mutations. This marks the sixth approval for Servier in cancers with IDH mutations. The approval is based on evidence from the INDIGO trial led by Patrick Wen, MD, and researchers at Dana-Farber. Vorasidenib was originally developed by Cambridge, MA-based Agios Pharmaceuticals, which sold its oncology portfolio to French pharma Servier in December 2020 for $1.8 billion upfront, with potential regulatory milestones of $200 million plus royalties. The drug has shown significant improvement in progression-free survival for patients compared to placebo.