Sysmex applies for a partial change for the OncoGuide™ NCC Oncopanel System

Sysmex Corporation 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 to include its use as a companion diagnostic for patients with advanced biliary tract cancer harboring FGFR2 gene1 rearrangements, including gene fusions.

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.
MB Bureau