已上市抗肿瘤药物增加新适应症技术指导原则

2018-12-04 MedSci MedSci原创

一、概述本指导原则的目的是指导申请人如何规划已上市抗肿瘤化学药物和生物制品增加新适应症的申请。本指导原则对抗肿瘤药物增加新适应症所需要的临床研究的要求进行讨论和说明。需明确的是,本指导原则中所指的增加的适应症应为肿瘤领域的新适应症,而且该适应症应为国内外均未批准的新适应症。已经上市的抗肿瘤药物增加非肿瘤领域新适应症的申请,不包含在本指导原则范围之内。二、背景对申请人而言,已上市的抗肿瘤药物递交

一、概述

本指导原则的目的是指导申请人如何规划已上市抗肿瘤化学药物和生物制品增加新适应症的申请。本指导原则对抗肿瘤药物增加新适应症所需要的临床研究的要求进行讨论和说明。需明确的是,本指导原则中所指的增加的适应症应为肿瘤领域的新适应症,而且该适应症应为国内外均未批准的新适应症。已经上市的抗肿瘤药物增加非肿瘤领域新适应症的申请,不包含在本指导原则范围之内。

二、背景

对申请人而言,已上市的抗肿瘤药物递交补充申请以增加新适应症存在积极和消极两方面的因素。积极因素包括:(1)可以给患者和临床医生提供经科学证实的最佳和最新治疗信息;(2)由于能用于更多的临床适应症,可能增加该药物的商业利润;(3)增加的适应症还有可能获得国家医保/社保部门或第三方保险公司的报销。消极因素包括:(1)需要一定资金和人力资源来完成新的临床研究以证实新适应症能够使患者获益;(2)需要一定资金和人力资源提交临床新适应症申报资料,以获得药政管理部门的批准;(3)有些情况下即使说明书中增加了新的适应症也并不能获得商业利润。例如:新增加的适应症是一个少见疾病或者该药物已不再处于专利保护的状态等等。

然而,药物说明书是为了提供某个药物的全面处方信息,其内容应包括药物所有具有足够数据证明其安全性和有效性的临床适应症等信息。当抗肿瘤药物上市后,在随后的临床实践中往往会出现许多新的用法和/或用途(新的适应症)。尽管这些新的用法和/或新的用途已经有临床研究发表数据的支持,但是这些信息却未被列入药物说明书中。为了更客观、科学地反映药物的处方信息,在已有的药物说明书中增加这些新的适应症是有必要的。

三、新申请需要的数据

为了增加已上市抗肿瘤药物说明书中的新适应症信息,申请人必须递交补充申请。补充申请资料中应提供与增加新适应症相关的所有临床研究资料,包括阴性结果、难以评价的结果和阳性结果。申请人必须提供足够数量的高质量资料来证明药物对新适应症的安全有效性,提供的资料应具有高度的可靠性。这是科学的要求,也是法规的要求。

(一)临床研究的要求

已上市的抗肿瘤药物增加新适应症应进行临床研究,所需要的临床研究要求取决于既往研究的有效性、安全性信息和新适应症的具体情况。如果增加的新适应症在临床上已经具有有效的治疗方法,即现有治疗方法能提供获益的状况下,通常应进行随机对照研究,并采用临床终点如生存期等,单臂试验或以替代指标来评价有效性的结果通常不能成为批准依据。例如,某药物被批准用于治疗晚期乳腺癌,那么,申请增加晚期肝癌的适应症应开展另一项以生存期为终点的充分良好对照的临床研究作为其支持依据。如果新增加的适应症在临床上尚无有效的治疗方法,即现有治疗方法不能提供显著获益的状况下,可考虑采用以安慰剂为对照组的随机对照研究或单臂临床研究的结果作为支持依据。研究终点可以选择生存期、无进展生存期等和/或者其他替代指标。具体要求参见《抗肿瘤药物临床研究技术指导原则》和《抗肿瘤药物终点指标的指导原则》。

关于安全性的要求:由于已上市药物的安全性特征在既往的临床研究中已明确,如果新适应症针对的用药人群、给药方案以及合并治疗等未出现重大变更,那么支持该药新适应症的申请所需要的安全性资料可以简化。但是,如果新适应症针对的用药人群、给药方案以及合并治疗等出现了重大变更,可能导致新的安全性问题,则应提供新的安全性信息。

增加新适应症申请包括以下情况:

1.增加新瘤种

申请增加新瘤种应进行临床研究以证明其在新患者人群中的安全性和有效性。例如,某药物被批准用于治疗晚期乳腺癌,那么,申请增加晚期肝癌的适应症应开展另一项充分良好对照的临床研究作为其支持依据。

2.增加新给药方案

新给药方案包括对已批准适应症的给药剂量的变更和用药时间变更等,目的是改善有效性、耐受性或依从性。申请增加新给药方案应进行临床研究以证明新的给药方案的安全性和有效性。例如某药物已经获得三周给药方案的批准,那么,申请增加每周给药方案也应以充分良好对照的临床研究作为其支持依据。

3.增加早期或晚期用药

某药已显示了用于某一肿瘤晚期治疗的安全有效性,申请增加该肿瘤早期治疗应进行临床研究以证明其安全有效性。例如某药物被批准用于治疗晚期乳腺癌,那么,申请增加乳腺癌的辅助治疗也应以充分良好对照的临床研究作为其支持依据。

4.增加三/二/一线用药

某药已显示了用于某一肿瘤某线治疗的安全有效性,申请增加该肿瘤其他分线治疗应进行临床研究以证明其安全有效性。例如某药物被批准用于治疗晚期乳腺癌的三线治疗,那么,申请增加乳腺癌的二线/一线治疗应以充分良好对照的多中心临床研究作为其支持依据。

5.增加单药或联合用药

某药已显示了用于某一肿瘤单药治疗的安全有效性,申请增加该肿瘤联合治疗应进行临床研究以证明其安全有效性。例如某药物被批准用于治疗晚期乳腺癌的单药治疗,那么,申请增加乳腺癌联合治疗应以充分良好对照的多中心临床研究作为其支持依据。

6.增加儿童用药或成人用药

由于成人和儿童的病理生理有所不同,因此,虽然药物在成人患者中已显示了安全性和有效性,但仍应在儿童中进行临床研究以证明该药在儿童中使用的安全有效性。研究结果应能证明儿童和成人的药代动力学数据相近,有效性和安全性研究结果也相似。儿童中进行临床研究的要求应视具体情况而定。具体要求参见《抗肿瘤药物临床研究技术指导原则》和《抗肿瘤药物终点指标的指导原则》。

同理,某药物在儿童中已显示了其安全性和有效性,仍应在成人中进行临床研究以证明该药在成人中使用的安全性和有效性。

所有上述例子是支持本指导原则涵盖的申请类型所需提供的临床研究的一般要求,但根据对药物认识的程度和所研究的特殊肿瘤适应症,有时针对不同的情况可能会有很多其他要求。鼓励申请人和国家食品药品监督管理局进行交流讨论。

(二)临床研究数据的来源

申请新适应症所提供的临床研究数据可以来源于两部分,一部分为制药企业发起的临床研究,另一部分为研究者发起的临床研究(IIT,Investigator Initiated Trial)。高质量的IIT结果也可以作为支持批准增加新适应症的重要参考。

对IIT提供的数据有如下要求: 临床研究机构应具有国家有关GCP法规要求的相应资质并有丰富的临床研究经验;主要研究者(PI,Principal Investigator)也应具有国家有关GCP法规要求的相应资质和丰富的临床研究经验,并在同行评议中获得较高学术地位;提供的资料应包括伦理委员会批件、详细的方案、研究数据(例如:病例记录表,CRF)、临床研究报告和统计分析报告;该研究应有严格、规范的质量管理体系,监查、稽查程序和记录。

在同行公认的、高水平的学术期刊上发表的有关临床研究的文献可作为IIT资料的补充支持信息。这些文献应该是符合国家GCP要求的、规范的临床研究报告,结果应能一致表明该药物在新肿瘤适应症中的安全性和有效性。除了期刊中已经公开的信息之外,申请人如果能补充提供更多的信息,如研究方案、详细的基线情况、统计数据库、病例记录表等,可作为更有力的证据来支持该新申请的批准。

采用研究者发起的临床研究(IIT)申请增加新适应症时,申请人还应提供在IIT研究和已发表研究文献中的研究者与该药物的商业利益无关的书面证明材料。 

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