Eisai Co., Ltd. has announced the launch of TASFYGO® Tablets 35mg (generic name: tasurgratinib succinate) in Japan for the treatment of patients with unresectable biliary tract cancer harboring FGFR2 gene fusions or rearrangements, who have experienced progression after chemotherapy. The product received manufacturing and marketing approval from Japan’s regulatory authorities on September 24, 2024, and was listed in Japan’s National Health Insurance Drug Price List today.
TASFYGO is a novel, orally available tyrosine kinase inhibitor selectively targeting FGFR1, FGFR2, and FGFR3. It was discovered and developed in-house at Eisai’s Tsukuba Research Laboratories.
The approval of TASFYGO in Japan is supported by data, including the results from a multicenter, open-label, single-arm Phase II clinical trial (Study 201) conducted by Eisai in Japan and China. Additionally, a companion diagnostic test, the “AmoyDx® FGFR2 Break-apart FISH Probe Kit” by Nihon Stery, Inc., was approved in August 2024 to detect FGFR2 gene fusions or rearrangements for patients with biliary tract cancer receiving TASFYGO.
Biliary tract cancer, which includes intrahepatic cholangiocarcinoma, has an estimated 22,000 patients in Japan. This cancer has a low five-year survival rate of about 25%, making it one of the most difficult cancers to treat, second only to pancreatic cancer. Treatment options are limited, contributing to a significant unmet medical need. Approximately 5-14% of intrahepatic cholangiocarcinoma cases are associated with FGFR2 gene fusions or rearrangements, which are known to play a crucial role in cancer cell proliferation, survival, migration, tumor angiogenesis, and drug resistance. These genetic aberrations are not only found in biliary tract cancer but also in several other cancer types, leading to growing interest in FGFRs as promising therapeutic targets.
TASFYGO is manufactured at Eisai’s Kawashima Industrial Park in Gifu Prefecture, using advanced Continuous Manufacturing and Real-Time Release Testing technologies. This production method ensures high product quality by integrating real-time quality monitoring throughout the manufacturing process, reducing human error, and offering greater control compared to conventional methods.
Eisai remains committed to addressing the diverse needs of cancer patients, their families, and healthcare professionals, by providing innovative treatment options like TASFYGO for biliary tract cancer with FGFR2 gene fusions or rearrangements.
