On March 15, 2023 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported 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 (Press release, Sysmex, MAR 15, 2023, View Source [SID1234628799]).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).

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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.