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A BRAF fusion joins another gene to the BRAF kinase, most often KIAA1549 in paediatric low-grade glioma. Tovorafenib is approved for children whose relapsed low-grade glioma carries a BRAF fusion or V600 mutation.
KIAA1549::BRAF is the hallmark of pilocytic astrocytoma and most paediatric low-grade gliomas; other partners and rare BRAF fusions occur in melanoma, thyroid and pancreatic acinar cancers. Fusions behave as class II alterations and respond poorly to first-generation BRAF inhibitors, which can paradoxically activate them. Tovorafenib (Ojemda, 2024) is labelled for patients 6 months and older with relapsed or refractory paediatric low-grade glioma harbouring a BRAF fusion or rearrangement or a BRAF V600 mutation; FoundationOne CDx is the listed companion diagnostic (P170019/S054). Detection needs RNA or DNA sequencing that captures rearrangements, or FISH; hotspot PCR misses them.
In plain words · BRAF is a signalling kinase mutated in half of melanomas; blocking it with two drugs at once became a template for targeted therapy.
In a child's low-grade glioma a BRAF fusion is common and, if the tumour comes back after treatment, makes tovorafenib an on-label option taken by mouth. The first-generation BRAF tablets used for V600E melanoma are not suitable for fusions. Ask whether the test used could see rearrangements, because some panels cannot.
Written only from the label or guideline text cited on this page. Not medical advice; your own report and the reading your team gives it come first.
A BRAF gene fusion or rearrangement (for example KIAA1549::BRAF) detected by RNA or DNA sequencing or FISH; hotspot PCR does not detect it.
“BRAF V600 mutations and BRAF fusions”
FDA: List of FDA-Authorized Companion Diagnostic Devices| Threshold | Drug | Cancer | Regulator | Source |
|---|---|---|---|---|
| BRAF fusion or rearrangement, or BRAF V600 mutation | Tovorafenib | Paediatric low-grade glioma | FDA | label |
| Device | Maker | Indication and sample | Drug | PMA / 510(k) |
|---|---|---|---|---|
| FoundationOne CDx | Foundation Medicine | Low-Grade Glioma - Tissue | Tovorafenib | P170019/S054 (01/16/2025) |
Matched on the name and aliases of the readout in the title, setting and summary of each trial; a match is a mention, not proof the readout was an entry criterion.
Shares FoundationOne CDx / Liquid CDx, Gene fusion and the tag biomarker.
Shares FoundationOne CDx / Liquid CDx, Gene fusion and the tag biomarker.
Shares FoundationOne CDx / Liquid CDx, Gene fusion and the tag biomarker.
Shares FoundationOne CDx / Liquid CDx, Gene fusion and the tag biomarker.
Shares FoundationOne CDx / Liquid CDx and the tag biomarker.
Shares FoundationOne CDx / Liquid CDx, Gene fusion and the tag biomarker.
Shares Gene fusion and the tag biomarker.
Shares FoundationOne CDx / Liquid CDx and the tag biomarker.