Chugai Obtains Approval for FoundationOne CDx Cancer Genomic Profile as a Companion Diagnostic of Tovorafenib for BRAF V600 Alterations and BRAF Fusion Gene-Positive Glioma

FoundationOne CDx Cancer Genomic Profile obtained approval as a companion diagnostic for glioma, expanding its companion diagnostic capabilities to cover 9 cancer types including solid tumors TOKYO, September 16, 2026 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on June 17, 2026 for FoundationOne ® CDx Cancer Genomic Profile to be used as a companion diagnostic for Ojemda ® Tablets 100 mg and Ojemda Dry Syrup 300 mg (generic name: tovorafenib), an anti-cancer agent/BRAF inhibitor, which IPSEN Co., Ltd. obtained a regulatory approval in Japan, for BRAF V600 alterations and BRAF fusion gene-positive glioma. This approval enables the detection of BRAF V600 alterations and BRAF fusion genes using the FoundationOne CDx Cancer Genomic Profile to guide the decision to use tovorafenib for BRAF V600 alterations and BRAF fusion gene-positive glioma. The efficacy and safety of tovorafenib for relapsed or progressive low-grade glioma with BRAF V600 alterations or BRAF fusion gene-positive were evaluated in an overseas Phase II clinical study (FIREFLY-1 study). IPSEN Co., Ltd. obtained a regulatory approval from the MHLW on September 16, 2026. FoundationOne CDx Cancer Genomic Profile has continuously expanded its companion diagnostic capabilities, enabling a single comprehensive genomic profiling test to support treatment decisions for multiple medicines. With the addition of a new companion diagnostic for glioma, the test now has companion diagnostic capabilities covering 9 cancer types including solid tumors. This is expected to further enhance its clinical utility. As a leading company in oncology, Chugai is committed to realizing more advanced personalized healthcare in the oncology field and contributing to patients through the wider adoption of comprehensive genomic profiling. Approval information The underlined and bolded part has been newly added. Intended uses or indications The product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers. The product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below. Alterations Cancer type Relevant drugs Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib, erlotinib, gefitinib, osimertinib EGFR exon 20 T790M alterations osimertinib ALK fusion genes alectinib, crizotinib, ceritinib, brigatinib ROS1 fusion genes entrectinib MET exon 14 skipping alterations capmatinib BRAF V600E and V600K alterations Malignant melanoma dabrafenib, trametinib, vemurafenib, encorafenib, binimetinib BRAF V600 alterations and BRAF fusion genes Glioma tovorafenib ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab AKT1 alterations capivasertib PIK3CA alterations PTEN alterations KRAS/NRAS wild-type Colorectal cancer cetuximab, panitumumab Microsatellite instability high nivolumab Microsatellite instability high Solid tumors pembrolizumab Tumor mutational burden high pembrolizumab NTRK1/2/3 fusion genes entrectinib, larotrectinib, repotrectinib RET fusion genes selpercatinib ALK fusion genes alectinib BRCA1/2 alterations Ovarian cancer olaparib BRCA1/2 alterations Prostate cancer olaparib FGFR2 fusion genes Biliary tract cancer pemigatinib About FoundationOne CDx Cancer Genomic Profile Developed by Foundation Medicine Inc. , FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan. Trademarks used or mentioned in this release are protected by law.

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