News
News
Press Release
Sysmex’s OncoGuide™ NCC Oncopanel System Receives Insurance Coverage as a Companion Diagnostic for Futibatinib, a Treatment for Advanced Biliary Tract Cancer
Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) announces that the OncoGuide™ NCC Oncopanel System (the “System”) is now covered by health insurance in Japan as a companion diagnostic for futibatinib,1 a treatment for unresectable biliary tract cancer2 harboring FGFR2 gene fusions3 that has progressed after chemotherapy. Futibatinib was developed by Taiho Pharmaceutical Co., Ltd. (HQ: Chiyoda-ku, Tokyo, Japan; President and Representative Director: Masayuki Kobayashi). Riken Genesis Co., Ltd (HQ: Shinagawa-ku, Tokyo, Japan; President: Kenji Iwakabe), a subsidiary of Sysmex, will begin assay services in Japan corresponding to this insurance coverage from September 2023.
Biliary tract cancer develops in approximately 26,000 patients annually in Japan.4 With a five-year survival rate of less than 30%,5 it has the second poorest cancer prognosis after pancreatic cancer. Currently, few treatment options exist for this disease, and no standard treatment has been established for locally advanced or metastatic biliary tract cancer that has progressed after first-line treatment. To address this, the development of molecular-targeted therapeutic agents targeting specific genetic abnormalities is actively underway.
In December 2018, the System received manufacturing and marketing approval in Japan as the country’s first cancer genome profiling6 test and obtained insurance coverage in June 2019. Sysmex has contributed to the promotion of cancer genomic medicine in Japan with a testing flow that can be conducted entirely within the country. Furthermore, Sysmex has been working with Taiho Pharmaceutical to develop a companion diagnostic for futibatinib. On February 28, 2023, Sysmex received approval for a partial change to the System to assist in identifying patients with biliary tract cancer eligible for futibatinib treatment. On June 26, Taiho Pharmaceutical received manufacturing and marketing approval for futibatinib in Japan, and the drug was listed in the NHI price list on August 30, 2023.
The System has now received insurance coverage as a new companion diagnostic for futibatinib in biliary tract cancer, in addition to its previously approved use for cancer genome profiling. Accordingly, Riken Genesis will begin providing assay services for this insurance-covered testing under quality assurance in accordance with international standards from September 2023. This will enable the identification of eligibility for futibatinib under insurance coverage and is expected to provide a new treatment option for patients with biliary tract cancer in the future.
Sysmex will continue its effort to create high-value testing and diagnostic technologies that support optimal healthcare for individual patients by collaborating with diverse stakeholders so that they can have a better healthcare journey.7
Overview of the Product and Insurance Coverage
(The underlined parts are new additions)
| Generic name |
Gene variants analysis set (for cancer genome profiling)
Somatic cell gene variants analysis set (for eligibility identification of antineoplastic agents)
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| Product name | OncoGuide™ NCC Oncopanel System | |
| Registration number in Japan | 23000BZX00398000 | |
| Intended use or effect |
・This product is used to obtain a comprehensive cancer genome profile in tumor tissues of patients with solid tumors.
・This product detects FGFR2 gene fusions to assist in identifying patients with biliary tract cancer eligible for futibatinib. |
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| National insurance coverage in Japan | D006-19 Cancer genome profiling: 44,000 points D004-2(4) Malignant tumor histology: FGFR2 gene fusion testing in biliary tract cancer: 5,000 points |
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| Manufactured and distributed by | Sysmex Corporation | |
| Target market | Japan |
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References
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Sysmex press release dated December 25, 2018: “Sysmex Receives Manufacturing and Marketing Approval to Use the OncoGuide™ NCC Oncopanel System in Cancer Genome Profiling”
Sysmex press release dated May 31, 2019: “The OncoGuide™ NCC Oncopanel System Receives Insurance Coverage for Use in Cancer Genome Profiling”
Sysmex press release dated February 15, 2021: “Sysmex Receives Approval for a Partial Change to the OncoGuide™ NCC Oncopanel System for Use in Cancer Genome Profiling - Detection of 10 New Gene Mutations Including MSH6 and PMS2, NTRK3 Gene Fusion and Microsatellite Instability -”
https://www.sysmex.co.jp/en/news/2021/pdf/210215.pdf
Sysmex press release dated March 15, 2023: “Sysmex Receives Approval for a Partial Change to the OncoGuide™ NCC Oncopanel System as a Companion Diagnostic to Futibatinib for Biliary Tract Cancer” https://www.sysmex.co.jp/en/news/2023/230315.html Taiho Pharmaceutical press release dated August 30, 2023: “Taiho Pharmaceutical Announces the Launch of FGFR Inhibitor LYTGOBI® Tablets 4mg in Japan”
*LYTGOBI® is a trademark of Taiho Pharmaceutical Co., Ltd.
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Terminology
| 1 |
Futibatinib:
A novel oral anticancer drug, developed by Taiho Pharmaceutical, that inhibits the proliferation of cancer cells by blocking the function of genetically abnormal proteins known as fibroblast growth factor receptors (FGFRs). In September 2022, the drug received accelerated approval in the US for the treatment of adult patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene fusions or other rearrangements. In July 2023, it received conditional marketing authorization in Europe for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (CCA) with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
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| 2 |
Biliary tract cancer:
A generic term for cancers that develop in the biliary tract, which are classified as bile duct cancer (including intrahepatic cholangiocarcinoma, which occurs in the bile ducts within the liver), gallbladder cancer, or papillary carcinoma, depending on their primary sites.
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| 3 | FGFR2 gene fusions: Four types of fibroblast growth factor receptors (FGFRs), FGFR1-4, have been identified. These are proteins involved in cell growth and proliferation. When FGFR genes with abnormalities, including fusion, mutation, and amplification, are activated they are thought to lead to cancer cell proliferation, survival, migration, tumor angiogenesis, and drug resistance, etc. In a study in Japan of patients with unresectable bile duct cancer, the positivity rate of FGFR2 gene rearrangement was reported to be 7.4% for intrahepatic cholangiocarcinoma and 3.6% for extrahepatic cholangiocarcinoma (hilar region). (Source: Maruki Y, et al., “Molecular detection and clinicopathological characteristics of advanced/recurrent biliary tract carcinomas harboring the FGFR2 rearrangements: a prospective observational study” (PRELUDE Study), J Gastorenterol. 2021 Mar; 56 (3): 250-260). |
| 4 |
Calculated based on the Cancer Information Service, National Cancer Center, Japan, Cancer Statistics (National Cancer Registry), National Cancer Incidence Data (2016-2018), and the Annual Report of Hospital-Based Cancer Registries, 2020 Nation-wide Aggregate Results (Tumor information).
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| 5 | Five-year net survival in the 2014-2015 diagnoses was 21.1% for intrahepatic cholangiocarcinoma and 27.2% for gallbladder cancer, according to the Cancer Information Service, National Cancer Center, Japan, “Annual Survival Report of Hospital-Based Cancer Registries”. |
| 6 |
Cancer genome profiling:
A test designed to obtain a comprehensive cancer genome profile in tumor tissues of patients with solid tumors, including advanced biliary tract cancer. Analyzing abnormalities in cancer-specific genes provides useful information for determining treatment methods, including diagnosis and selection of potentially effective anti-cancer drugs.
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| 7 |
Sysmex is proposing the concept of a “healthcare journey.” We view the various healthcare-related events a person experiences throughout their lives (life stages), along with the corresponding process this involves (such as treatment at healthcare institutions), as a “journey”. Through various collaborations, we aim to offer new value to improve each individual’s healthcare journey, and to become an essential presence in society.
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About Sysmex Corporation
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Sysmex is a global company that supports the health of people in over 190 countries and regions worldwide. The “Sysmex Way”, the corporate philosophy of the Sysmex Group, defines Sysmex’s mission as “Shaping the advancement of healthcare.” We specialize in in vitro diagnostics, which involves blood, urine, and other specimens. Sysmex is committed to creating further innovations in this field, as well as venturing into new areas such as surgical support robots, to improve the lifelong healthcare journey of each individual. Sysmex continues to deliver new value through its unique technologies and solutions, as it collaborates creatively with a variety of partners to support people's universal desire to live longer and healthier lives. For more information about Sysmex, please visit www.sysmex.co.jp/en/.
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About Taiho Pharmaceutical Co., Ltd.
| Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd. (https://www.otsuka.com/en/), is an R&D-driven specialty pharma focusing on the fields of oncology, allergy and immunology. Its corporate philosophy takes the form of a pledge: “We strive to improve human health and contribute to a society enriched by smiles.” In the field of oncology, in particular, Taiho Pharmaceutical is known as a leading company in Japan for developing innovative medicines for the treatment of cancer, a reputation that is rapidly expanding through their extensive global R&D efforts. In areas other than oncology, as well, the company creates and markets quality products that effectively treat medical conditions and can help improve people’s quality of life. Always putting customers first, Taiho Pharmaceutical also aims to offer consumer healthcare products that support people’s efforts to lead fulfilling and rewarding lives. For more information about Taiho Pharmaceutical, please visit https://www.taiho.co.jp/en/ |
Sysmex’s Materiality
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Sysmex has identified “Creating new value for a healthy society” as one of the issues that we prioritize (materiality), and we are working toward the resolution of medical issues through innovation. Going forward, Sysmex is committed to supporting the universal desire of people to live long and healthy lives, and contributing to the realization of optimal medical care for each individual through our unique technologies and solutions.
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- The purpose of this news release is to communicate our business activities to our stakeholders. It may or may not include information about Sysmex's products or their research and development, but this is not intended for promotion, advertising or medical advice. The information contained in this news release is current as of the date of the announcement but may be subject to change without prior notice.