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卫材抗癌药物”TASFYGO®片剂35mg”在日本上市

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November 22, 2024
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卫材抗癌药物”TASFYGO®片剂35mg”在日本上市
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用于治疗携带FGFR2基因融合或重排的胆道癌

东京2024年11月22日 /美通社/ — 卫材宣布,已在日本上市成纤维细胞生长因子受体(FGFR)选择性酪氨酸激酶抑制剂”TASFYGO®片剂35mg”(通用名:tasurgratinib succinate),用于治疗化疗后病情进展的、携带FGFR2基因融合或重排的不可切除胆道癌患者。该产品于2024年9月24日获得日本的生产和销售许可,并于11月20日被列入日本国家医疗保险药品价格名录。

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TASFYGO,由卫材(Eisai)筑波研究实验室自主研发,是一种可口服的新型酪氨酸激酶抑制剂,对FGFR1、FGFR2和FGFR3表现出选择性抑制活性。TASFYGO在日本获批是基于多项数据,包括卫材在日本和中国开展的一项多中心、开放性、单臂临床II期试验(研究201)的结果[1]。2024年8月,Nihon Stery, Inc.(总部:东京)研发的配套诊断试剂盒”AmoyDx® FGFR2 Break-apart FISH Probe Kit”也获批上市,该试剂盒用于检测胆道癌患者的FGFR2基因融合或重排,以确定是否适合使用TASFYGO进行治疗[2]。

据估计,日本胆道癌患者人数约为 22,000 人[3],[4],五年相对生存率约为 25%[3],是继胰腺癌之后预后第二差的难治性癌症。与其他癌症相比,胆管癌的药物治疗方案十分有限,因此存在大量未满足的医疗需求。胆道癌中有15-30%为肝内胆管癌,其中又有约5-14% 存在 FGFR2 基因融合或重排[5],[6],[7]。FGFR遗传变异(如:基因融合)被认为与癌细胞的增殖、存活和迁移以及肿瘤血管生成和耐药性密切相关。鉴于在其他各种癌症和胆道癌中都观察到了FGFR遗传变异,FGFR作为癌症治疗的潜在靶点正日益受到关注。

TASFYGO 在川岛工业园(岐阜县)生产,采用创新的连续生产和实时放行检测技术,这种生产技术可确保生产过程中的产品质量。连续生产是一种生产方法,从原材料输入到制剂形成的整个过程都是连续进行的。通过采用实时质量监控技术,将多个生产流程整合在一起,实现自动生产。与专注于产品放行检测的传统工艺相比,这种方法可以利用生产过程中的数据,通过自动化减少人为错误,从而实现更高的质量控制。

卫材致力于通过为携带FGFR2基因融合或重排的胆道癌患者提供TASFYGO这一全新治疗选择,不断努力满足癌症患者其家属以及医疗专业人士的多样化需求,并为他们带来更多福祉。

1. Furuse J. et al. Pivotal single-arm, phase 2 trial of tasurgratinib for patients with fibroblast growth factor receptor (FGFR)-2 gene fusion-positive cholangiocarcinoma (CCA). 2024 ASCO Gastrointestinal Cancers Symposium;

Abstract No. 471. https://ascopubs.org/doi/pdf/10.1200/JCO.2024.42.3_suppl.471 

2. AmoyDx® FGFR2 Break-apart FISH Probe Kit Approved as Companion Diagnostic for Eisai’s Tasurgratinib in Japan.

Available at: https://www.amoydiagnostics.com/about/press-releases/245 Last accessed: September 2024.

3. Latest statistics, Cancer Information Service, National Cancer Center, Japan. (Japanese only)

4. The 23rd Follow-up Survey Reports for Primary Liver Cancer Cases in Japan (2014-2015), 2023. (Japanese only)

5. Arai Y. et al., Fibroblast growth factor receptor 2 tyrosine kinase fusions define a unique molecular subtype of cholangiocarcinoma, Hepatology, 2014, 59, 1427-1434.

6. Maruki Y. et al., Molecular detection and clinicopathological characteristics of advanced/recurrent biliary tract carcinomas harboring the FGFR2 rearrangements: a prospective observational study (PRELUDE Study), J Gastroenterol. 2021; 56(3), 250-260.

7. Tsujie M. et al., Fibroblast growth factor receptor 2 (FGFR2) fusions in Japanese patients with intrahepatic

cholangiocarcinoma, Jpn J Clin Oncol. 2021; 51(6): 911-917.

8. Miyano SW. et al., E7090, a Novel Selective Inhibitor of Fibroblast Growth Factor Receptors, Displays Potent Antitumor Activity and Prolongs Survival in Preclinical Models, Molecular Cancer Therapeutics, 2016, 15, 2630-2639.

9. Kawano S. et al., Antitumor Activity of Tasurgratinib as an Orally Available FGFR1-3 Inhibitor in Cholangiocarcinoma Models With FGFR2-fusion, Anticancer Research, 2024, 44, 2393-2406.

 

SOURCE 卫材株式会社

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