FDA Approves Companion Diagnostic To Identify Patients With Grade 2 IDH-Mutant Glioma Eligible for Vorasidenib

The FDA and Thermo Fisher Scientific announced today the approval of the Ion Torrent Oncomine Dx Target Test (Thermo Fisher Scientific) as a companion diagnostic to identify patients eligible for treatment with vorasidenib (Voranigo; Servier Pharmaceuticals, LLC) tablets.¹

Gliomas are one of the most common types of brain tumor. | Image Credit: © Saiful52 | stock.adobe.com

Vorasidenib is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor. Earlier this year, it was granted FDA approval for the treatment of adult and pediatric individuals 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation after surgery. This includes biopsy, sub-total resection, or gross total resection.^1,2

“Voranigo 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,” David K Lee, CEO of Servier Pharmaceuticals, said in a news release. “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.”¹

Gliomas are one of the most common malignant primary brain tumors in adults and represents approximately 81% of these tumors. Furthermore, mutation with IDH impacts 20% of patients who are diagnosed with primary malignant brain tumors and adult-type diffuse gliomas. Testing for these mutations in patients represented an unmet health need, until the FDA’s approval today.^1,2

IDH mutation testing is recommended in all patients with gliomas, according to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology, which have made this recommendation for many years. They note that accurate determination of a patient’s IDH status has a major impact on the diagnosis of gliomas and patient prognosis.¹

The Oncomine Dx Target Test, a next-generation sequencing (NGS)-based device, was previously granted FDA approval as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who harbor an activating human epidermal growth factor receptor 2 (HER2) mutation who could possibly benefit from fam-trastuzumab deruxtecan-nxki (Enhertu). In addition to NSCLC, it has also received approval in cholangiocarcinoma, medullary thyroid cancer, and thyroid cancer.^1,3

According to Thermo Fisher Scientific, the test can deliver biomarker results for multiple targeted therapies in one sample, which can quickly match patients to the correct therapy for them.¹

“As the health care system works to realize the impact of precision medicine, patients must have access to the proper testing that helps unlock targeted treatment options based on their unique genomic profiles,” Kathy Davy, president, clinical next-generation sequencing at Thermo Fisher Scientific, said in the news release. “Combining our CDx technology with Servier’s breakthrough therapy will help dramatically impact care for patients with aggressive brain tumors.”¹

REFERENCES

1. Thermo Fisher Scientific. FDA approves NGS-based companion diagnostic for first targeted therapy for patients with grade 2 IDH-mutant glioma. BusinessWire. News Release. Released October 21, 2024. Accessed October 21, 2024. https://businesswire.com/news/home/20241018070557/en/FDA-Approves-NGS-Based-Companion-Diagnostic-for-First-Targeted-Therapy-for-Patients-with-Grade-2-IDH-Mutant-Glioma

2. McGovern G. FDA approves vorasidenib for adults, pediatric patients with grade 2 astrocytoma, oligodendroglioma. Pharmacy Times. Published August 7, 2024. Accessed October 21, 2024. https://www.pharmacytimes.com/view/fda-approves-vorasidenib-for-adults-pediatric-patients-with-grade-2-astrocytoma-oligodendroglioma

3. PT Staff. FDA approves companion diagnostic for trastuzumab deruxtecan in HER2-mutated non-small cell lung cancer. Pharmacy Times. Published August 17, 2022. October 21, 2024. https://www.pharmacytimes.com/view/fda-approves-companion-diagnostic-for-trastuzumab-deruxtecan-in-her2-mutated-non-small-cell-lung-cancer