基石药业(02616.HK)精准治疗产品艾伏尼布(ivosidenib)获美国FDA优先审评用于治疗胆管癌
近日，创新生物药企基石药业(02616.HK)授权引进的精准治疗产品艾伏尼布(Tibsovo，ivosidenib片剂)的补充新药申请(sNDA)已获美国食品药品监督管理局(FDA)受理，用于治疗携带异柠檬酸脱氢酶-1(IDH1)突变的经治胆管癌患者，并被纳入优先审评，审评时间从10个月缩短到6个月。
所属施维雅(Servier Pharmaceuticals)公司肿瘤管线的艾伏尼布是一款口服IDH1靶向抑制剂，最初由Agios Pharmaceuticals(以下简称“Agios”)公司开发，2018年基石药业与Agios达成在大中华区开发及商业化艾伏尼布的独家协议，并于2020年将其临床开发和商业化授权区域从大中华区扩展至新加坡。同年10月，艾伏尼布被纳入中国国家药品监督管理局(NMPA)药品审评中心发布的“临床急需境外新药名单(第三批)”，充分显示了艾伏尼布优越的临床优势。
此外，艾伏尼布因治疗急性骨髓性白血病而获得FDA快速通道和孤儿药资格，并于2018年7月获美国FDA批准上市，用于治疗IDH1突变复发/难治急性髓系白血病(R/R AML)的成人患者。基石药业产品管线中包括艾伏尼布、舒格利单抗、阿伐替尼、普拉替尼在内的4款药物均获得了美国FDA突破性疗法认定。
此次，FDA优先审评资格的授予是基于名为ClarIDHy的3期临床试验数据。该研究是全球首个针对携带IDH1突变的经治胆管癌患者的随机3期临床试验。试验结果显示，与安慰剂组相比，艾伏尼布治疗组达到无进展生存期(PFS)的主要终点，将患者疾病进展或死亡风险降低63%。同时，艾伏尼布也改善了患者的总生存期(OS)。
胆管癌是一种侵袭性很强的肿瘤，手术切除是治疗胆管癌的首要方法。许多患者被诊断时已为疾病中晚期，因此错失手术机会。目前，对于晚期胆管癌，尚无标准二线和三线治疗方案。患者通常预后差并且生存期短。胆管癌可能与多种高风险因素有关，包括病毒性肝炎及华支睾吸虫感染等。中国是乙肝和华支睾吸虫感染的流行地区，也是世界上胆管癌发病率最高的国家之一。
基石药业专注于创新肿瘤免疫治疗及精准治疗药物的开发及商业化，不仅建立了由14条候选药物组成的新药管线，更在2021年迎来商业化加速的收获期：在递交新药上市申请的两年多时间里就迎来国内首个精准治疗药物普吉华®(普拉替尼胶囊)在大陆地区获批上市，用于治疗RET基因融合阳性非小细胞肺癌患者。同月内，泰吉华®(阿伐替尼片)也获得了国家药监局批准上市，成为中国首个获批用于治疗PDGFRA外显18突变的胃肠道间质瘤的药物，泰時维®(阿伐替尼片)也刚刚在中国台湾地区获批上市。此外，普拉替尼针对甲状腺癌的适应症新药上市申请已获NMPA受理并被纳入优先审评。
为推动创新药尽快惠及中国患者，近日，在获批上市仅一个月左右，泰吉华®实现了在北京大学肿瘤医院、北京大学人民医院、上海交通大学医学院附属仁济医院等近三十家医院同步开出首批处方单，面向全国多个省市的五十多家院内和院外药房供药。
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