The Ion Torrent Oncomine Dx Target Test is the first FDA-approved next generation sequencing-based diagnostic. Credits: JHVEPhoto / Shutterstock.

Thermo Fisher Scientific has announced that its in vitro diagnostic test, Oncomine, has won US Food and Drug Administration (FDA) approval for use as a companion diagnostic in grade 2 IDH-mutant glioma.

As per the 21 October press announcement, Oncomine is now approved to be used to identify patients who are eligible for treatment with Servier Pharmaceuticals’ Voranigo (vorasidenib) tablets.

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Voranigo, which gained FDA approval in August 2024, is the first and only targeted therapy available for patients with grade 2 IDH-mutant glioma. The French drugmaker gained control over the asset in 2020 after purchasing Agios’ oncology pipeline for $1.8bn in 2020. Agios has since sold its royalty stake in Voranigo to Royalty Pharma for $905m. Under the terms of the agreement, Royalty Pharma will gain a 12% royalty on annual US sales up to $1bn and a 12% royalty on net US sales over $1bn.

As a once-daily oral inhibitor of IDH1 and IDH2 enzymes, Voranigo is indicated for use in grade 2 IDH-mutant glioma patients following surgery, including biopsy or gross total resection.

The Ion Torrent Oncomine Dx Target Test is the first FDA-approved sequencing-based diagnostic. Oncomine received its first approval as a companion diagnostic in 2017 and subsequently gained approval in August 2022 as a companion diagnostic for identifying non-small cell lung cancer (NSCLC) patients eligible for treatment with Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki). 

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Oncomine is also approved for use in cholangiocarcinoma (CCA), medullary thyroid cancer (MTC) and thyroid cancer (TC).

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Daiichi and AstraZeneca’s Enhertu has seen several wins this year. The drug gained conditional approval in China earlier this month and a breakthrough therapy designation for a specific type of breast cancer in August 2024. Additionally, in April, the treatment was granted accelerated approval for the treatment of unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive [immunohistochemistry (IHC) 3+] solid tumours.

According to GlobalData’s consensus forecasts, Voranigo is expected to generate sales of $37m in 2030. Enhertu is projected to generate total sales of $13bn in 2030. GlobalData is the parent company of Pharmaceutical Technology.