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Review
. 2025 Apr;85(4):585-590.
doi: 10.1007/s40265-025-02153-5. Epub 2025 Mar 4.

Tasurgratinib Succinate: First Approval

Yvette N Lamb  1
Affiliations
Review

Tasurgratinib Succinate: First Approval

Yvette N Lamb. Drugs. 2025 Apr.

Abstract

Tasurgratinib succinate (TASFYGO®; Eisai Co., Ltd.) is an orally active, small molecule inhibitor of fibroblast growth factor receptors (FGFRs) 1, 2, and 3 being developed for the treatment of solid tumors, including cholangiocarcinoma (i.e., bile duct cancer) and breast cancer. Tasurgratinib succinate received its first approval on 24 September 2024 in Japan, for the treatment of FGFR2 fusion-positive unresectable biliary tract cancer that has progressed after chemotherapy. The approval was based on the positive results of an open-label, single-arm, multicenter, phase II study conducted in Japan and China. This article summarizes the milestones in the development of tasurgratinib succinate leading to this first approval for biliary tract cancer.

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Conflict of interest statement

Declarations. Conflict of interest: During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Yvette Lamb is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content. Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability: Not applicable.

References

    1. Eisai Co. Ltd. Anticancer agent TASFYGO® tablets 35 mg (tasurgratinib succinate) approved in Japan for biliary tract cancer with FGFR2 gene fusions or rearrangements [media release]. 24 Sept 2024. http://www.eisai.com .
    1. Eisai Co. Ltd. Tasurgratinib (TASFYGO®): Japanese prescribing information. 2024. https://www.pmda.go.jp/ . Accessed 26 Nov 2024.
    1. Sahu R, Sharma P, Kumar A. An insight into cholangiocarcinoma and recent advances in its treatment. J Gastrointest Cancer. 2023;54(1):213–26. - DOI - PubMed
    1. Watanabe Miyano S, Yamamoto Y, Kodama K, et al. E7090, a novel selective inhibitor of fibroblast growth factor receptors, displays potent antitumor activity and prolongs survival in preclinical models. Mol Cancer Ther. 2016;15(11):2630–9. - DOI - PubMed
    1. Conci S, Catalano G, Roman D, et al. Current role and future perspectives of immunotherapy and circulating factors in treatment of biliary tract cancers. Int J Med Sci. 2023;20(7):858–69. - DOI - PubMed - PMC

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