FDA Approves NGS-Based Test for Grade 2 IDH-Mutant Glioma Therapy

Thermo Fisher Scientific has announced that the U.S. Food and Drug Administration (FDA) has approved its Ion Torrent™ Oncomine™ Dx Target Test as a companion diagnostic (CDx) for identifying patients eligible for treatment with Servier Pharmaceuticals’ VORANIGO® (vorasidenib) tablets. VORANIGO is the only FDA-approved treatment for Grade 2 IDH-mutant glioma and is specifically designed for adult and pediatric patients aged 12 and older who have undergone surgery for this type of brain cancer.

VORANIGO functions as an inhibitor of isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2), and is aimed at treating Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation. This approval is significant as it marks the first targeted therapy for Grade 2 IDH-mutant glioma, providing a new treatment avenue for patients who previously had limited options.

Gliomas are the most prevalent form of malignant primary brain tumors in adults, constituting approximately 81% of such cases. About 20% of these gliomas have an IDH mutation, making it essential to test for these mutations to make informed treatment decisions. The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology recommend IDH mutation testing for all glioma patients due to its significant impact on diagnosis and prognosis. With the FDA approval of VORANIGO, determining a patient’s IDH mutation status becomes even more crucial.

David K. Lee, CEO of Servier Pharmaceuticals, emphasized the importance of this breakthrough, noting that VORANIGO is the first targeted therapy for Grade 2 IDH-mutant glioma in nearly 25 years. He highlighted the importance of identifying key driver mutations to ensure that patients receive the most appropriate treatment at the right time.

In addition to its approval for IDH-mutant diffuse glioma, the Oncomine Dx Target Test has previously received approvals for other cancer indications, including non-small cell lung cancer (NSCLC), cholangiocarcinoma (CCA), medullary thyroid cancer (MTC), and thyroid cancer (TC). This companion diagnostic test provides comprehensive biomarker results from a single sample, facilitating the rapid matching of patients with the appropriate targeted therapies.

Kathy Davy, president of clinical next-generation sequencing at Thermo Fisher Scientific, discussed the significance of precision medicine and the need for proper testing to unlock targeted treatment options based on a patient's genomic profile. She expressed enthusiasm for the collaboration with Servier Pharmaceuticals, which aims to dramatically improve care for patients with aggressive brain tumors through the integration of CDx technology with breakthrough therapies.

The FDA's approval of the Oncomine Dx Target Test expands its clinical indications and it is now approved and reimbursed by both government and commercial insurers in 19 countries, covering over 550 million lives globally. Following this approval, Thermo Fisher Scientific and Servier Pharmaceuticals plan to continue their collaboration on additional companion diagnostics, including the Ion Torrent™ Oncomine Dx Express Test. Available on the Ion Torrent Genexus™ Dx System, this test can provide results in just one day, significantly speeding up the process of matching patients with optimal treatments based on their genomic data.

Thermo Fisher Scientific is recognized as the world leader in serving science, with annual revenue exceeding $40 billion. Their mission is to support customers in making the world healthier, cleaner, and safer through a combination of innovative technologies and pharmaceutical services.