Sysmex Corporation (HQ: Kobe, Chairman and CEO: Hisashi Ietsugu) 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.
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Taiho Pharmaceutical press release dated July 28, 2022: “Taiho Pharmaceutical Submits New Drug Application of FGFR inhibitor futibatinib (TAS-120) for Biliary Tract Cancer”
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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”
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Sysmex press release dated May 31, 2019: “The OncoGuide™ NCC Oncopanel System Receives Insurance Coverage for Use in Cancer Genome Profiling”
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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 –”
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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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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 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.
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5 | 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”. |
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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.
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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.
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