FDA approves vorasidenib for Grade 2 gliomas with IDH mutations

Vorasidenib has been approved by the U.S. Food and Drug Administration (FDA) for patients with Grade 2 gliomas with IDH1 or IDH2 mutations.

Based on evidence from the INDIGO clinical trial, a global phase 3, double-blinded, randomized clinical trial, 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 to remove the tumor. INDIGO was the first phase 3 clinical trial of a molecularly targeted therapy for IDH-mutant glioma. The INDIGO trial shows that IDH inhibitors can work in low grade gliomas with the IDH mutation.

The last drug that was approved for low grade gliomas was in 1999, so this will be the first new drug in a long time." 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 Grade 2 gliomas are incurable brain tumors.

IDH mutations are found in the vast majority of lower grade gliomas. A key benefit of vorasidenib therapy is that it can delay the need for treatment with radiation and chemotherapy. Current treatment involves surgery followed by radiation and chemotherapy.

Radiation and chemotherapy are effective treatments, but after many years of treatment, patients will experience signs of cognitive dysfunction normally seen in much older people. "These patients are often young, in their 30s or 40s. But ten to twenty years later, even if they are doing well .