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FDA Approves Servier's Voranigo for IDH-Mutated Gliomas

NextEdge Admin

09 Aug 2024

1 min 46 sec

The US Food and Drug Administration has approved Servier Pharmaceuticals' Voranigo (vorasidenib) as a treatment for patients with IDH1- or IDH2-mutated grade 2 astrocytoma or oligodendroglioma. This approval is for both adult and pediatric patients older than 12 who have previously undergone surgical interventions, such as biopsy, subtotal resection, or gross total resection. Voranigo's approval is grounded in the positive outcomes of the Phase III INDIGO clinical trial, where patients with IDH1/2-mutated residual or recurrent grade 2 glioma who were treated with Voranigo showed a significant improvement in survival. They lived a median of 27.7 months compared to 11.1 months for those who received a placebo. The INDIGO trial involved 331 patients, and the determination of IDH1/2 mutation status in tumors was performed using Thermo Fisher Scientific's next-generation sequencing test, Oncomine Dx.

Voranigo is the latest addition to Servier's growing portfolio of IDH enzyme inhibitors. The company also markets Idhifa (enasidenib), which is approved for the treatment of advanced IDH2-mutant acute myeloid leukemia, and Tibsovo (ivosidenib), approved for patients with IDH1-mutated acute myeloid leukemia and IDH1-mutated cholangiocarcinoma.