Thermo Fisher's Oncomine Test Wins FDA Approval for VORANIGO Treatment

Thermo Fisher Scientific, the global leader in scientific services, has been granted FDA approval for its Ion Torrent™ Oncomine™ Dx Target Test as a companion diagnostic to select patients suitable for treatment with Servier Pharmaceuticals, LLC’s VORANIGO® (vorasidenib) tablets.

VORANIGO is a medication that inhibits isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) for treating Grade 2 astrocytoma or oligodendroglioma patients aged 12 and above with IDH1 or IDH2 mutation after surgery. VORANIGO, the initial targeted therapy for Grade 2 IDH-mutant glioma, offers a fresh treatment approach for patients with very few options.

Gliomas account for around 81% of primary malignant brain tumors in adults, making them the most widespread type. Around 20% of those individuals have an IDH mutation and it is crucial to test for these mutations in order to make precise treatment choices. Additionally, the NCCN Clinical Practice Guidelines in Oncology advise IDH mutation testing for all glioma patients, recognizing its significance in glioma diagnosis and prognosis. The status of IDH mutation has been a major factor in the NCCN treatment guidelines for many years. The FDA's approval of VORANIGO will make it even more essential to determine the IDH mutation status of glioma patients.