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Jun 22, 2021

Chugai Obtains Regulatory Approval for FoundationOne CDx Cancer Genomic Profile to be Used as Companion Diagnostic for MSI-High Tumors

  • FoundationOne CDx Cancer Genomic Profile was approved as a companion diagnostic for nivolumab and pembrolizumab for the treatment of patients with microsatellite instability high (MSI-High) tumors

TOKYO, June 22, 2021 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on June 21, 2021, for FoundationOne® CDx Cancer Genomic Profile to be used as a companion diagnostic (CDx) for both a human anti-human PD-1 monoclonal antibody, Opdivo® [generic name: nivolumab (genetical recombination)] and a humanized anti-human PD-1 monoclonal antibody, Keytruda® [generic name: pembrolizumab (genetical recombination)] for the treatment of patients with microsatellite instability high (MSI-High) tumors.

“High microsatellite instability has been identified in tumors in various organs, and immune-checkpoint inhibitors can be a therapeutic option. FoundationOne CDx Cancer Genomic Profile is characterized by the ability to comprehensively capture information on individual gene alterations, as well as the ability to detect microsatellite instability,” said Dr. Osamu Okuda, Chugai’s President and CEO. “Through testing with FoundationOne CDx Cancer Genomic Profile, we will contribute to ensuring as many patients as possible to have access to optimal treatments.”

As a companion diagnostic, FoundationOne CDx Cancer Genomic Profile will be used to identify patients with MSI-High unresectable advanced or recurrent colorectal cancer that have progressed following chemotherapy who may benefit from nivolumab. It will also be used to identify patients with microsatellite instability (MSI-H) solid tumors that have advanced or relapsed after chemotherapy (limited to use when difficult to treat with standard of care), who may benefit from pembrolizumab.

As a leading company in the field of oncology, Chugai is committed to realizing advanced personalized oncology care and contributing to patients and healthcare professionals through improving access to comprehensive genomic profiling of cancers.

Approval information The underlined 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.
AlterationsCancer typeRelevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
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
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab (genetical recombination)
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)
NTRK1/2/3 fusion gene entrectinib, larotrectinib sulfate
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.

About Microsatellite instability high (MSI-High)
The genome contains several short strings of DNA (deoxyribonucleic acid) called microsatellites that are repeated many times. High-frequency microsatellite instability (MSI-High) is an abnormal number of microsatellite repeats1). Abnormal microsatellites do not lead to cancer, but tissues that show MSI-High are thought to be more likely to develop cancer. MSI-High has been found in patients with cancer of various organs, including endometrial, gastric, small intestine, colorectal, ovarian, renal pelvis/ureteral, prostate, and breast cancers2, 3). MSI-High is also a hallmark of people with Lynch syndrome who are born with genomic alterations that predispose them to developing cancer3).

Trademarks used or mentioned in this release are protected by laws.


  1. Nojadeh, J.N. et al.: Microsatellite instability in colorectal cancer. EXCLI J. 17: 159-168, 2018.
  2. Japan Society of Cancer Therapy/Japanese Society of Clinical Oncology: Guidelines for Transversal Genomic Practice in Organs in Adult and Pediatric Advanced Solid Tumors, Second Edition, October 2019
  3. Colorectal Cancer Study Group: Hereditary Colorectal Cancer Guidelines 2020 Version


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