Pharmaceutical Technology

Thermo Fisher’s Oncomine gains FDA approval as brain tumor diagnostic

As a companion diagnostic, Oncomine will be used to identify patients eligible for treatment with Servier’s Voranigo.

Justine Ra October 21 2024

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.

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).

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

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.