FDA Approves Thermo Fisher’s Oncomine for Brain Tumor Diagnosis

Thermo Fisher Scientific has achieved a significant milestone with the approval of its in vitro diagnostic test, Oncomine, by the US Food and Drug Administration (FDA) for its use as a companion diagnostic in grade 2 IDH-mutant glioma. This approval, announced on October 21, signifies that Oncomine can now be employed to identify patients eligible for treatment with Servier Pharmaceuticals’ Voranigo (vorasidenib) tablets.

Voranigo, approved by the FDA in August 2024, stands out as the first and only targeted therapy for patients with grade 2 IDH-mutant glioma. The French pharmaceutical company Servier obtained control over Voranigo in 2020 through a substantial acquisition of Agios’ oncology pipeline for $1.8 billion. Subsequently, Agios sold its royalty stake in Voranigo to Royalty Pharma for $905 million. Under the terms of this deal, Royalty Pharma is entitled to a 12% royalty on annual US sales of Voranigo up to $1 billion, with the same percentage applied to net US sales exceeding $1 billion.

Voranigo is a once-daily oral inhibitor targeting IDH1 and IDH2 enzymes. It is specifically indicated for use in patients with grade 2 IDH-mutant glioma who have undergone surgery, which includes procedures such as biopsy or gross total resection.

The Ion Torrent Oncomine Dx Target Test has the distinction of being the first FDA-approved sequencing-based diagnostic. Initially approved as a companion diagnostic in 2017, Oncomine has since expanded its approvals. In August 2022, it received approval to identify non-small cell lung cancer (NSCLC) patients eligible for treatment with Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki). Beyond its application in NSCLC, Oncomine is approved for use in cholangiocarcinoma (CCA), medullary thyroid cancer (MTC), and thyroid cancer (TC).

Daiichi Sankyo, in collaboration with AstraZeneca, has experienced a series of successes with Enhertu. The drug received conditional approval in China earlier this month and gained breakthrough therapy designation for a particular type of breast cancer in August 2024. Additionally, Enhertu was granted accelerated approval in April for treating unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive solid tumors, which are identified through immunohistochemistry (IHC) 3+ testing.

GlobalData projects that Voranigo will generate sales amounting to $37 million by 2030. Enhertu, on the other hand, is anticipated to achieve total sales of $13 billion by the same year. Notably, GlobalData is affiliated with Pharmaceutical Technology.

The approval of Oncomine as a companion diagnostic and the corresponding approval of Voranigo underscore the continuing advancements in targeted therapies and diagnostic tools in oncology. These developments not only provide new treatment avenues for patients but also highlight the importance of personalized medicine in improving patient outcomes in cancers with specific genetic mutations.