FDA approves NGS-Based Companion Diagnostic for First Targeted Therapy for Patients with Grade 2 IDH-Mutant Glioma

October 23, 2024- Thermo Fisher Scientific has received approval from the U.S. Food and Drug Administration (FDA) for its Ion Torrent™ Oncomine™ Dx Target Test as a companion diagnostic (CDx) to identify patients eligible for treatment with Servier Pharmaceuticals, LLC’s VORANIGO® (vorasidenib) tablets. Gliomas are the most common malignant primary brain tumor in adults, representing approximately 81% of primary malignant brain tumors. Of those, approximately 20% harbor an IDH mutation and testing for these mutations is essential for accurate treatment decisions.

As the first targeted therapy for Grade 2 IDH-mutant glioma, VORANIGO provides a new care path for patients with extremely limited treatment options.

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