Chugai: FoundationOne CDx approved as companion diagnostic for tovorafenib in BRAF‑altered/fusion glioma
- MHLW approved FoundationOne CDx as a companion diagnostic for tovorafenib for BRAF V600 alterations and BRAF fusion gene–positive glioma on June 17, 2026.
- IPSEN obtained MHLW approval for tovorafenib (Ojemda) on September 16, 2026, following an overseas Phase II FIREFLY‑1 study in relapsed or progressive low‑grade glioma with those alterations.
- With this addition, FoundationOne CDx’s companion diagnostic coverage extends to nine cancer types, including solid tumors.
- FoundationOne CDx is an NGS‑based assay that detects substitutions, indels, copy‑number alterations in 324 genes, select rearrangements, microsatellite instability and tumor mutational burden from FFPE tumor tissue.
Regulatory approval
The Ministry of Health, Labour and Welfare approved FoundationOne CDx Cancer Genomic Profile on June 17, 2026 for use as a companion diagnostic to guide use of tovorafenib (Ojemda) for glioma with BRAF V600 alterations or BRAF fusion genes. IPSEN obtained regulatory approval for tovorafenib from the MHLW on September 16, 2026.
Clinical basis
Efficacy and safety of tovorafenib for relapsed or progressive low‑grade glioma with BRAF V600 alterations or BRAF fusion genes were evaluated in an overseas Phase II clinical study (FIREFLY‑1), which supported the regulatory filings.
Companion‑diagnostic scope
The approval expands FoundationOne CDx’s companion diagnostic capabilities to cover nine cancer types including solid tumors, allowing a single comprehensive genomic profiling test to support treatment decisions across multiple targeted therapies.
Test capabilities and intended use
FoundationOne CDx is an NGS‑based in vitro diagnostic that detects substitutions, insertions/deletions, copy‑number alterations in 324 genes, select rearrangements, and genomic signatures including MSI and TMB from FFPE tumor tissue. It is intended for comprehensive genomic profiling of tumor tissues in patients with solid cancers and for detecting alterations to support assessment of indicated drugs.
Source: Chugai Pharmaceutical