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Nov 20, 2025
- Pharmaceuticals
- R&D
Chugai Obtains Approval for FoundationOne CDx Cancer Genomic Profile to Be Used as a Companion Diagnostic for Repotrectinib with NTRK Fusion-Positive Solid-Tumors
- FoundationOne CDx Cancer Genomic Profile obtained approval as a companion diagnostic for repotrectinib to identify patients with NTRK fusion-positive solid-tumors
- As a result, the companion diagnostic indications have been expanded to 8 cancer types and a total of 28 drugs
TOKYO, November 20, 2025 –– Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on October 3, 2025 for FoundationOne®CDx Cancer Genomic Profile to be used as a companion diagnostic for Augtyro® (repotrectinib), an anti-cancer agent/tyrosine kinase inhibitor for NTRK fusion-positive solid-tumors. Bristol-Myers Squibb K.K. obtained a partial change approval for the manufacturing and marketing authorization of Augtyro in Japan.
“We are pleased that FoundationOne CDx Cancer Genomic Profile was approved as a companion diagnostic for repotrectinib for identifying NTRK fusion-positive solid-tumors patients. We believe that being able to comprehensively identify with a single comprehensive genomic profiling test, rare genetic mutations that occur at low frequencies across cancer types, such as NTRK fusion genes, is useful for informing optimal treatment plans for patients. We will continue to contribute to the advancement of personalized healthcare based on each patient’s genetic mutation status by expanding companion diagnostics,” said Dr. Osamu Okuda, Chugai’s President and CEO.
This approval enables the detection of NTRK1/2/3 fusion genes using the FoundationOne CDx Cancer Genomic Profile to guide the decision to use repotrectinib for NTRK fusion-positive solid-tumor patients. The efficacy and safety of repotrectinib for NTRK fusion-positive advanced or recurrent solid-tumors were evaluated in the international Phase I/II clinical study (TRIDENT-1) and overseas Phase I/II pediatric clinical study (CARE). Bristol Myers Squibb K.K. obtained approval from the MHLW on November 20, 2025.
As a oncology leading company, Chugai is committed to realizing advanced personalized healthcare in oncology and contributing to patients through the expansion 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 dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate, dacomitinib hydrate |
| EGFR exon 20 T790M alterations | osimertinib mesylate | |
| ALK fusion genes | alectinib hydrochloride, crizotinib, ceritinib, brigatinib | |
| ROS1 fusion genes | entrectinib | |
| MET exon 14 skipping alterations | capmatinib hydrochloride hydrate | |
| BRAF V600E and V600K alterations | Malignant melanoma | dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib, encorafenib, binimetinib |
| ERBB2 copy number alterations (HER2 gene amplification positive) | Breast cancer | trastuzumab (genetical recombination) |
| AKT1 alterations | capivasertib | |
| PIK3CA alterations | ||
| PTEN alterations | ||
| KRAS/NRAS wild-type | Colorectal cancer | cetuximab (genetical recombination), panitumumab (genetical recombination) |
| Microsatellite instability high | nivolumab (genetical recombination) | |
| Microsatellite instability high | Solid tumors | pembrolizumab (genetical recombination) |
| Tumor mutational burden high | pembrolizumab (genetical recombination) | |
| NTRK1/2/3 fusion genes | entrectinib, larotrectinib sulfate, repotrectinib | |
| RET fusion genes | selpercatinib | |
| BRCA1/2 alterations | Ovarian cancer | olaparib |
| BRCA1/2 alterations | Prostate cancer | olaparib, talazoparib tosilate |
| 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.
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