Thermo Fisher Scientific, has received U.S. Food and Drug Administration (FDA) approval for its Ion Torrent™ Oncomine™ Dx Target Test as a companion diagnostic for Servier Pharmaceuticals’ VORANIGO® (vorasidenib) tablets. This approval marks a significant step in the treatment of Grade 2 IDH-mutant gliomas, offering a new targeted therapy option for patients with few alternatives.
VORANIGO, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, is designed to treat adult and pediatric patients aged 12 and older who have undergone surgery for gliomas with IDH1 or IDH2 mutations. Gliomas, the most common malignant brain tumors in adults, often harbor IDH mutations, which affect approximately 20% of cases. The availability of this new therapy highlights the importance of genetic testing to guide treatment decisions.
David K. Lee, CEO of Servier Pharmaceuticals, emphasized the significance of this approval: “VORANIGO is the first and only targeted therapy for patients with Grade 2 IDH-mutant glioma, a rare and incurable type of brain cancer that has lacked new treatments for nearly 25 years. Identifying key mutations is critical in ensuring patients receive the right treatment at the right time.”
The FDA approval reinforces the role of precision medicine in oncology, where identifying genetic mutations can directly influence patient outcomes. The National Comprehensive Cancer Network (NCCN) guidelines already recommend IDH mutation testing for glioma patients, underscoring its importance in diagnosis, prognosis, and now, treatment planning with VORANIGO.
Thermo Fisher’s Oncomine Dx Target Test has previously gained FDA approval for use in several other cancers, including non-small cell lung cancer (NSCLC), cholangiocarcinoma (CCA), medullary thyroid cancer (MTC), and thyroid cancer (TC). This companion diagnostic offers healthcare providers a streamlined approach to biomarker testing, delivering multiple biomarker results from a single sample. It allows for faster and more precise patient-matching with targeted therapies, significantly improving treatment timelines.
“Ensuring patients have access to the right diagnostic tests is key to realizing the full potential of precision medicine,” said Kathy Davy, President of Clinical Next-Generation Sequencing at Thermo Fisher Scientific. “By partnering with Servier, we’re connecting patients with the newest targeted therapies for aggressive brain tumors, helping to revolutionize care for these conditions.”
The approval of the Oncomine Dx Target Test is part of an ongoing collaboration between Thermo Fisher and Servier Pharmaceuticals. The companies are also developing the Oncomine Dx Express Test, which will be available on the Ion Torrent Genexus™ Dx System. This system promises to deliver rapid genomic testing results in as little as one day, accelerating the pace at which patients can be matched with the most appropriate treatments.