On November 20, 2024 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has launched fibroblast growth factor receptor (FGFR) selective tyrosine kinase inhibitor "TASFYGO Tablets 35mg" (generic name: tasurgratinib succinate) in Japan for the treatment of patients with unresectable biliary tract cancer with FGFR2 gene fusions or rearrangements that progressed after cancer chemotherapy (Press release, Eisai, NOV 20, 2024, View Source [SID1234648514]). The product received manufacturing and marketing approval in Japan on September 24, 2024, and was published in Japan’s National Health Insurance Drug Price List today.
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Discovered in-house by Eisai’s Tsukuba Research Laboratories, TASFYGO is an orally available novel tyrosine kinase inhibitor that demonstrates selective inhibitory activity against FGFR1, FGFR2 and FGFR3.
The approval of TASFYGO in Japan is based on data such as the results of a multicenter, open-label, single-arm clinical phase II trial (Study 201) conducted by Eisai in Japan and China.1 A companion diagnostic test to detect FGFR2 gene fusions or rearrangements for the use of TASFYGO in biliary tract cancer, "AmoyDx FGFR2 Break-apart FISH Probe Kit" by Nihon Stery, Inc. (Headquarters: Tokyo) was approved in August 2024.2
The estimated number of patients in Japan with biliary tract cancer is approximately 22,000,3,4 with approximately 25% of the five-year relative survival rate,3 making it an intractable cancer with the second worst prognosis following pancreatic cancer. Since drug therapy options are limited in comparison with other cancers, it is a disease with significant unmet medical needs. FGFR2 gene fusions or rearrangements are observed in approximately 5-14% of intrahepatic cholangiocarcinoma, which accounts for 15-30% of biliary tract cancers.5,6,7 FGFR genetic aberrations such as the gene fusions are known to be deeply involved in the proliferation, survival and migration of cancer cells as well as tumor angiogenesis and drug resistance. As these genetic aberrations in FGFRs have been observed in various other types of cancers as well as biliary tract cancer, there is growing interest in FGFRs as a promising target for cancer therapy.
TASFYGO is produced at the Kawashima Industrial Park (Gifu Prefecture), using innovative Continuous Manufacturing and Real Time Release Testing, a manufacturing technology that ensures product quality within production processes. Continuous Manufacturing is a production method in which processing is carried out continuously from raw material input to formulation. By incorporating real-time quality monitoring technology, multiple manufacturing processes are integrated, enabling automatic production. This method allows for higher quality control compared to conventional processes that focus on product release testing, by utilizing data within the manufacturing process and reducing human-error through automation.
Eisai aims to make continuous efforts to meet the diversified needs of and increase the benefits provided to patients with cancer, their families, and healthcare professionals, by delivering TASFYGO as a new treatment option for biliary tract cancer with FGFR2 gene fusions or rearrangements.