癌症免疫治疗产品的监管以及 FDA 在产品开发和临床评估中的作用。

Regulation of immunotherapeutic products for cancer and FDA's role in product development and clinical evaluation.

机构信息

Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), Rockville, MD, USA.

Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Rockville, MD, USA.

出版信息

J Immunother Cancer. 2013 May 29;1:5. doi: 10.1186/2051-1426-1-5. eCollection 2013.

DOI:10.1186/2051-1426-1-5

PMID:24764535

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3986979/

Abstract

Immunotherapeutics include drugs and biologics that render therapeutic benefit by harnessing the power of the immune system. The promise of immune-mediated therapies is target specificity with a consequent reduction in off-target side effects. Recent scientific advances have led to clinical trials of both active and passive immunotherapeutic products that have the potential to convert life-ending diseases into chronic but manageable conditions. Clinical trials investigating immunotherapeutics are ongoing with some trials at advanced stages of development. However, as with many products involving novel mechanisms of action, major regulatory and scientific issues arising with clinical use of immunotherapeutic products remain to be addressed. In this review, we address issues related to different immunotherapeutics and provide recommendations for the characterization and evaluation of these products during various stages of product and clinical development.

摘要

免疫疗法包括通过利用免疫系统的力量来产生治疗效果的药物和生物制剂。免疫介导疗法的承诺是靶向特异性，从而减少脱靶副作用。最近的科学进步导致了主动和被动免疫治疗产品的临床试验，这些产品有可能将危及生命的疾病转化为慢性但可管理的疾病。正在进行免疫治疗的临床试验，其中一些试验处于开发的后期阶段。然而，与许多涉及新作用机制的产品一样，免疫治疗产品临床应用中出现的主要监管和科学问题仍有待解决。在这篇综述中，我们讨论了与不同免疫疗法相关的问题，并为这些产品在产品和临床开发的各个阶段的特性描述和评估提供了建议。