FDA Approves Companion Diagnostic for Vorasidenib in IDH-Mutant Glioma

• The Ion Torrent Oncomine Dx Target Test is now approved as a companion diagnostic to identify patients eligible for treatment with vorasidenib (Voranigo), targeting IDH-mutant diffuse glioma.
• This test delivers biomarker results for multiple therapies from a single sample, allowing for quick matching of patients to the appropriate targeted treatments.
• Vorasidenib, a selective inhibitor of mutant IDH1/IDH2, is FDA-approved for patients 12 and older with IDH-mutant grade 2 glioma.

The FDA has approved the Ion Torrent Oncomine Dx Target Test as a companion diagnostic to identify patients eligible for vorasidenib treatment, a targeted therapy for the treatment of patients with IDH-mutant diffuse glioma.¹

The Ion Torrent Oncomine Dx Target Test is a distributable companion diagnostic which simultaneously delivers biomarker results for multiple targeted therapies from 1 sample. Additionally, it helps to match patients with the right targeted therapies in a timely fashion.

Vorasidenib is an oral, selective, highly brain-penetrant dual inhibitor of mutant IDH1 and IDH2 enzymes for the treatment of IDH-mutant diffuse glioma. In August of this year, the FDA approved the agent for the treatment of patients 12 and older with IDH-mutant, grade 2 astrocytoma or oligodendroglioma, based on findings from the pivotal phase 3 INDIGO trial (NCT04164901).²

“[Vorasidenib] is the first and only targeted therapy for patients living with grade 2 IDH mutant glioma, a relentless and incurable type of brain cancer that hasn’t seen treatment advances in nearly 25 years,” said David K Lee, chief executive officer of Servier Pharmaceuticals, in a press release.¹ “As more targeted therapies become available to patients, identifying key driver mutations is essential to help the right patients find the right treatment, at the right time.”

In addition to this approval of the Ion Torrent Oncomine Dx Target Test for patients with IDH-mutant diffuse glioma, the test has previously received approvals for the treatment of patients with non–small cell lung cancer, cholangiocarcinoma, medullary thyroid cancer, and thyroid cancer.

REFERENCES:

1. Thermo Fisher Scientific. FDA approves NGS-based companion diagnostic for first targeted therapy for patients with grade 2 IDH-mutant glioma. News release. Thermo Fisher Scientific. October 21, 2024. Accessed October 21, 2024. https://tinyurl.com/mrxhrsbd

2. FDA approves vorasidenib for grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation. News release. FDA. August 6, 2024. Accessed October 21, 2024. https://tinyurl.com/3jv48wa9