5月16日,中国国家药监局药品审评中心(CDE)公示将和誉医药的ABSK-011胶囊(通用名:依帕戈替尼/Irpagratinib)纳入突破性治疗品种,拟用于治疗既往接受过免疫检查点抑制剂(ICI)和多靶点酪氨酸激酶抑制剂(mTKI)治疗失败的FGF19过表达晚期肝细胞癌患者。疗效数据上,作为全球首个针对FGF19/FGFR4信号通路异常激活的小分子抑制剂,它在2023年ESMO年会上公布的Ib期...
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