抗癌剂“TASFYGO®片35mg”(tasurgratinib琥珀酸酯)在日本批准在带有FGFR2基因融合或重新安排Eisai Co.,Ltd.有限公司(总部:Tokyo:Tokyo,CEO:Haruo Naito and Isalrory for Advorruation and eisai and over for for for Figran)的胆道癌或重新排列的胆道癌。日本的受体(FGFR)选择性酪氨酸激酶抑制剂“TASFYGO®TASFYGO®片剂35mg”(Tasurgratinib琥珀酸酯)(tasurgratinib琥珀酸酯)用于治疗患有FGFR2基因融合或重排的不可切除的胆道癌患者,这些患者在癌症化学治疗后进展。在日本,它已收到卫生,劳动和福利部(MHLW)的孤儿药物,并于2023年12月提交了营销授权申请。此批准基于数据,例如由Eisai在日本和中国进行的多中心,开放标签,单臂临床II期试验(研究201)的结果。研究201招募了63例患有不可切除的晚期或转移性胆管癌患者,该患者具有FGFR2基因融合或以前用基于吉西他滨的组合化疗治疗的重排。这项研究的主要终点是客观响应率(ORR),次要终点包括安全性。1这项研究达到了其主要终点,并超过了具有统计学意义的预先指定的肿瘤反应阈值(15%):用独立成像综述评估,用TasFygo治疗的患者的ORR为30.2%(90%置信区间(CI):20.7-41.0)。治疗 - 急性不良事件(发生率为25%或以上)是高磷酸血症(81.0%),棕榈 - 翼展红细胞炎综合征(44.4%),腹泻(44.4%),腹泻(36.5%)(36.5%),天冬氨酸氨基糖化酶增加(31.7%),Alanity Amin(28.7%)(28.7%)(28.7%)(28.7%)(28.7%)(31.7%)(28.7%) (25.4%)。
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