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基石药业-B(02616.HK)获批开展ivosidenib桥接注册性I期试验用于治疗急性髓性白血病
格隆汇 07-22 07:34

格隆汇7月22日丨基石药业-B(02616.HK)公布,已获得国家药监局(NMPA)批准,启动ivosidenib(TIBOSOVO)在中国的一项桥接注册性I期试验,以治疗携带IDH1基因突变的复发或难治性(R/R)急性髓性白血病(AML)患者。

这项独立试验旨在验证ivosidenib在携带异柠檬酸脱氢酶-1(IDH1)基因突变的R/RAML在中国患者中的有效性、安全性和药代动力学。

公告显示,AML是成人中最常见的急性白血病,且疾病进展迅速。美国每年约有20,000例AML新发病例,患者五年生存率约为27%,而在中国每年新发病例超过30,000例,五年生存率低于20%。大部分AML患者会对治疗产生耐药或最终复发,发展为预后很差的R/RAML。

随着中国人口的平均寿命延长和老龄人口增多,AML的发病率可能呈显着上升趋势。在所有AML病例中,约6%至10%存在由IDH1基因突变导致的造血干细胞分化受阻。目前已经在中国获批的AML疗法中,还没有针对该患者群体的有效药物。

据悉,ivosidenib由基石药业的合作伙伴AgiosPharmaceuticals,Inc.发现和研发,已于2018年7月获得美国食药监局(FDA)批准,用于治疗经FDA批准的测试检测到的携带IDH1基因突变的成人R/RAML患者。

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