Great news! New Glioma Drug Approved for First Time in Decades

The FDA has approved the first drug, vorasidenib for glioma patients with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation. IDH mutations are found in the vast majority of lower grade gliomas. 

Vorasidenib is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor. It was approved for patients with Grade 2 gliomas with IDH1 or IDH2 mutations. Current treatment of these patients involves surgery followed by radiation and chemotherapy, but after many years of treatment, they may experience signs of cognitive dysfunction. Being able to delay radiation and chemotherapy could thus greatly improve patients’ quality of life.

The approval was based on evidence from the INDIGO clinical trial, a global phase III, in which vorasidenib more than doubled progression-free survival and delayed the need for treatment with radiation and chemotherapy for patients with Grade 2 IDH-mutant glioma after surgery. The drug also had a manageable safety profile. “Tolerability is important because this is a drug that we expect people to be on for many years.” Says Patrick Y. Wen, MD, director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute and one of the trial’s three study chairs.  

Source: Inside Precision Medicine, August 8, 2024

Benedikte Hasselbalch, MD, PhD
Consultant, neurooncologist
Department of Oncology
University Hospital Copenhagen