On November 20, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on October 3, 2025 for FoundationOneCDx 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.
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"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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(Press release, Chugai, NOV 20, 2025, View Source [SID1234660845])