Voranigo (vorasidenib), a dual IDH1/2 inhibitor, receives a positive opinion from the EMA’s CHMP for adults and adolescents with grade 2 IDH-mutant glioma following surgery.
The phase 3 INDIGO trial demonstrated a marked extension of progression-free survival and delayed need for further anticancer interventions with Voranigo compared to placebo.
Voranigo would be the first targeted therapy for this indication in Europe, addressing a major unmet need in low-grade glioma management.
Safety profile is manageable, with most adverse events related to liver enzymes and mild systemic symptoms.
Background
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This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.