- For Print
- November 20, 2024
亚洲彩票官网., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “亚洲彩票官网”) announced today 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. 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.
Discovered in-house by 亚洲彩票官网’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 亚洲彩票官网 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.
亚洲彩票官网 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.
Media Inquiries:
Public Relations Department,
亚洲彩票官网., Ltd.
+81-(0)3-3817-5120
[Notes to editors]
1. Product Information
Brand name: TASFYGO® Tablets 35mg
Generic name: Tasurgratinib succinate
Indications: Unresectable biliary tract cancer with FGFR2 gene fusions or rearrangements that progressed after cancer chemotherapy
Dosage and Administration: The usual adult dose of tasurgratinib is 140mg orally once daily under fasting conditions. The dose may be reduced appropriately according to the condition of the patient.
National Health Insurance (NHI) Drug Price: TASFYGO Tablets 35 mg: \ 15,378.70 (per 1 tablet)
Packaging: TASFYGO Tablets 35 mg: 56 tablets (14 tablet PTP sheet X 4)
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