On September 6, 2022 Sysmex Corporation (HQ: Kobe, Chairman and CEO: Hisashi Ietsugu) reported that applied on September 2, 2022 for a partial change of the manufacturing and marketing approval for the OncoGuide NCC Oncopanel System, a gene mutation analysis set (the "System") to include its use as a companion diagnostic for patients with advanced biliary tract cancer harboring FGFR2 gene1 rearrangements, including gene fusions (Press release, Sysmex, SEP 6, 2022, View Source [SID1234619009]).

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Biliary tract cancer2 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 which progresses after first-line treatment. Development is actively underway in pursuit of molecular-targeted therapeutic agents that target specific genetic abnormalities such as FGFR2 gene rearrangements, which are believed to be closely related to cancer cell survival and proliferation.

In 2018, Sysmex became the first company in Japan to receive manufacturing and marketing approval for such a system for use in cancer genome profiling.6 The company has since contributed to the promotion of cancer genomic medicine by promptly delivering the System to various medical institutions. Sysmex has also been working on the development of a companion diagnostic device aimed at commercialization, jointly with Taiho Pharmaceutical Co., Ltd. (HQ: Chiyoda-ku, Tokyo; President and Representative Director: Masayuki Kobayashi), which is developing futibatinib7 (generic name), an FGFR inhibitor for the treatment of locally advanced or metastatic biliary tract cancer harboring FGFR2 gene rearrangements, including gene fusions, in Japan.

Sysmex has recently applied for a partial change of the System’s approval in Japan to include its use as a companion diagnostic for patients with biliary tract cancer, to determine indications of futibatinib. Taiho Pharmaceutical applied on July 28, 2022, for manufacturing and marketing approval for futibatinib for the treatment of previously treated locally advanced or metastatic biliary tract cancer harboring FGFR2 gene rearrangements, including gene fusions. If, through these initiatives, the System can be used to determine indications for the use of futibatinib in the future, it will provide another treatment option to 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 that will lead to offering optimal treatment for each patient, while also contributing to the development and evolution of personalized medicine.

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)

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.

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).

5-year relative survival rate:
An index that indicates how much lower the percentage of individuals diagnosed with a certain type of cancer who are alive after five years is than the percentage of the entire Japanese population who are alive after five years.

Five-year relative survival rates in the 2013-2014 diagnosis are 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".

Cancer genome profiling:
A test designed to obtain a comprehensive cancer genome profile in tumor tissues for analysis of 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.

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 or other therapies. In May 2018, futibatinib was granted orphan drug status for the treatment of cholangiocarcinoma, and also received Breakthrough Designation for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions in April 2021 from the US FDA. In March 2022, the FDA accepted the New Drug Application (NDA) for futibatinib for priority review.