Cancer Treatment Today

FDA has approved Voranigo (vorasidenib), an isocitrate dehydrogenase-1 and isocitrate dehydrogenase-2 inhibitor, for the treatment of adult and pediatric patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection. he approval of Voranigo is supported by results from INDIGO (NCT04164901), a randomized, multicenter, double-blind, placebo-controlled trial.

The results of INDIGO were published in The New England Journal of Medicine and presented during the plenary session at the 2023 annual meeting of the American Society of Clinical Oncology. The trial showed that Voranigo significantly extended progression-free survival and time to next intervention, when compared to placebo.

However, NCCN recommends this drug also for grade 3 disease. Voranigo (vorasidenib), a drug for certain brain tumors, was safe and well toleratedin patients with grade 3 or 4 IDH-mutant gliomas, according to short-term data presented at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting in Honolulu, Hawaii.
There is clinical evidence regarding the effectiveness of this drug for this indication as published in the authoritative, peer-reviewed medical and scientific literature.

Konteatis Z, Artin E, Nicolay B, Straley K, Padyana AK, Jin L, Chen Y, Narayaraswamy R, Tong S, Wang F, Zhou D, Cui D, Cai Z, Luo Z, Fang C, Tang H, Lv X, Nagaraja R, Yang H, Su SM, Sui Z, Dang L, Yen K, Popovici-Muller J, Codega P, Campos C, Mellinghoff IK, Biller SA. Vorasidenib (AG-881): A First-in-Class, Brain-Penetrant Dual Inhibitor of Mutant IDH1 and 2 for Treatment of Glioma. ACS Med Chem Lett. 2020 Jan 22;11(2):101-107

“Experience with vorasidenib in patients with grade 3 or 4 IDH-mutant gliomas,” by Amanda Knott. Presented at 2025 Society of Neuro-Oncology Annual Meeting; Nov. 19-23, 2025; Honolulu, HI. Abstract NCOG-44.

NCCN CNS Cancer 2024, GLIO-A, 2 of 9

Voranigo Prescribing Information 2024