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News
Press Release
Sysmex Receives Approval for a Partial Change to the OncoGuide™ NCC Oncopanel System as a Companion Diagnostic to Futibatinib for Biliary Tract Cancer
Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announces that as of February 28, 2023, Sysmex has received approval for a partial change to its OncoGuide™ NCC Oncopanel System (the “System”) for use as a companion diagnostic to futibatinib (generic name)1 for patients with biliary tract cancer.2 Futibatinib is a molecular-targeted agent currently under development by Taiho Pharmaceutical Co., Ltd. (HQ: Chiyoda-ku, Tokyo, Japan; President and Representative Director: Masayuki Kobayashi).
Biliary tract cancer is known to develop in approximately 26,000 patients annually in Japan,3 with a 5-year relative survival rate4 of less than 30%,5 and has the second poorest prognosis of any cancer after pancreatic cancer. At present, this disease has few treatment options, and no standard treatment has been sufficiently established for locally advanced or metastatic biliary tract cancer that has progressed after first-line treatment. Development is actively underway in pursuit of molecular-targeted therapeutic agents that target specific genetic abnormalities such as FGFR2 gene6 rearrangements, which are believed to be closely related to cancer cell survival and proliferation.
In 2018, Sysmex became the first manufacturer in Japan to receive manufacturing and marketing approval for a system for use in cancer genome profiling.7 The Company has since contributed to the promotion of cancer genomic medicine in Japan with a testing flow that can be conducted entirely in Japan, while promptly providing the testing to various medical institutions. Sysmex was working on the development of a companion diagnostic device aimed at commercialization, jointly with Taiho Pharmaceutical, which is developing futibatinib, an FGFR inhibitor for the treatment of previously treated locally advanced or metastatic biliary tract cancer harboring FGFR2 gene rearrangements, including gene fusions. On September 2, 2022, Sysmex applied for a partial change with an additional intended use for the System in Japan. Taiho Pharmaceutical applied for manufacturing and marketing approval for futibatinib in Japan on July 28, 2022.
Sysmex has received approval for a partial change to the System to include its use as a companion diagnostic for futibatinib for biliary tract cancer, in addition to cancer genome profiling. This approval will allow the System to be used to detect FGFR2 gene fusions by analyzing gene rearrangements, thereby assisting in identifying patients with biliary tract cancer who may be eligible for futibatinib. Sysmex will press forward with its efforts aimed at early insurance coverage and market introduction in Japan. If this test is available with insurance coverage in the future, it is expected to provide another treatment option for patients with locally advanced or metastatic biliary tract cancer.
Sysmex will continue to work on the early commercialization of high-value testing and diagnostic technologies to offer optimal treatment for each patient, while also contributing to the development and evolution of personalized medicine.
Product Overview (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 |
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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 –”
Taiho Pharmaceutical press release dated July 28, 2022: “Taiho Pharmaceutical Submits New Drug Application of FGFR inhibitor futibatinib (TAS-120) for Biliary Tract Cancer”
Sysmex press release dated September 6, 2022: “Sysmex Applies for a Partial Change for the OncoGuide™ NCC Oncopanel System as a Companion Diagnostic for the Treatment of Advanced Biliary Tract Cancer – Contributing to the Development of Cancer Genomic Medicine through Partnerships with Pharmaceutical Companies – “
Taiho Pharmaceutical press release dated October 3, 2022: “U.S. FDA Approves FGFR Inhibitor, Futibatinib for the Treatment of Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma”
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Terminology
| 1 |
Futibatinib (development code: TAS-120):
A novel oral anticancer drug currently under development by Taiho Pharmaceutical for the treatment of patients with advanced solid tumors with FGFR1-4 genetic aberrations, including biliary tract cancer, who were previously treated with chemotherapy. In September 2022, the US FDA granted the drug accelerated approval for indications for previously treated unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions or other rearrangements.
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| 2 |
Biliary tract cancer:
A generic term for cancers that develop in the biliary tract, which are classified into 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 | 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-year relative survival rate:
An index that indicates the percentage of individuals diagnosed with a certain type of cancer who are alive after five years to the percentage of the entire Japanese population who are alive after five years.
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| 5 | Five-year relative survival rates in the 2013-2014 diagnosis were 20.6% for intrahepatic cholangiocarcinoma and 29.4% for gallbladder cancer, according to the Cancer Information Service, National Cancer Center, Japan, “Annual Survival Report of Hospital-Based Cancer Registries”. |
| 6 |
FGFR2 gene:
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, 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).
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| 7 |
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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About Sysmex Corporation
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In line with its mission of “shaping the advancement of healthcare,” which is defined in the “Sysmex Way,” the corporate philosophy of the Sysmex Group, Sysmex works to contribute to the development of healthcare and the healthy lives of people. Sysmex conducts integrated R&D, manufacturing and sales, and provides support services for its instruments, reagents and software for in vitro testing of blood, urine and other bodily fluids. Sysmex supplies its products to medical institutions in more than 190 countries and regions throughout the world. In recent years, Sysmex has been expanding its business in the life science domain, using proprietary technologies to create new testing and diagnostic value, realize healthcare that is optimized for individual patients, and help reduce patients’ burdens and enhance their quality of life.
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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, and urology. 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 "Resolution of medical issues through products and services" as one of the issues that we prioritize (materiality) as we work to develop and supply products with high clinical value. Leveraging our proprietary technology and the global network that we have cultivated thus far, we continue to strive to contribute to the development of healthcare and the healthy lives of people.
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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.