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Servier Reports the CHMP’s Positive Opinion Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma 

Shots: 

  • The CHMP has recommended to Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery but do not currently require radiotherapy or CT; anticipated EC decision in all 30 EEA states 
  • The CHMP opinion is based on the global P-III (INDIGO) trial (N=331), which included VORANIGO (n=168) or PBO (n=163). Among them, oligodendroglioma (n=172; 88 Voranigo; 84 PBO) and astrocytoma (n=159; 80 Voranigo and 79 PBO) were presented at ASCO’23 and published in the NEJM 
  • Voranigo (40mg Tablets) is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor 

Ref: PRNewswire | Image: Servier| Press Release

Related News:- Servier Reports the US FDA’s Approval of Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma 

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