NEW YORK – The US Food and Drug Administration on Tuesday approved Servier Pharmaceuticals' IDH inhibitor Voranigo (vorasidenib) as a treatment for patients with IDH1- or IDH2-mutated grade 2 astrocytoma or oligodendroglioma.
The FDA approved Voranigo for adult and pediatric patients older than 12 who have already undergone surgery, including biopsy, subtotal resection, or gross total resection. The approval is based on the results of the Phase III INDIGO clinical trial in which patients with IDH1/2-mutated residual or recurrent grade 2 glioma lived for a median 27.7 months when they were treated with Voranigo versus 11.1 months when they received placebo. The trial included 331 patients whose tumors were tested for IDH1/2 mutation status with Thermo Fisher Scientific's next-generation sequencing test, Oncomine Dx.
Voranigo joins Servier's commercially available IDH enzyme inhibitors Idhifa (enasidenib), which is approved for advanced IDH2-mutant acute myeloid leukemia, and Tibsovo (ivosidenib), which is approved for IDH1-mutated AML and IDH1-mutated cholangiocarcinoma.
In February 2024, Suresnes, France-based Servier also filed for Voranigo's approval for treating grade 2 IDH-mutated glioma in Europe.