Hum Vaccin Immunother. 2012 Sep;8(9):1335-53. doi: 10.4161/hv.20518. Epub 2012 Aug 16.
Cancer immunotherapy has seen a tremendous number of failures and only few recent regulatory successes. This is a review dedicated to determine major regulatory and developmental issues around cancer immunotherapeutics. A three pillar approach should be used in setting a development path: discovery platforms and sufficient pool of validated tumor antigens, product development strategy enabling to bring the product closer to the patient and clinical development strategy accounting for competitive landscape, treatment paradigm, technical and commercial risks. Regulatory framework existing around cancer vaccines in the EU, US, Japan and some developing countries is outlined. In addition, the review covers some specific issues on the design and conduct of clinical trials with cancer vaccines.
癌症免疫疗法已经经历了大量的失败，只有少数最近的监管成功。这是一篇专门探讨癌症免疫疗法的主要监管和发展问题的综述。在制定发展路径时，应该采用三支柱方法：发现平台和充足的验证肿瘤抗原库、使产品更接近患者的产品开发策略以及考虑竞争格局、治疗模式、技术和商业风险的临床开发策略。概述了欧盟、美国、日本和一些发展中国家现有的癌症疫苗监管框架。此外，该综述还涵盖了癌症疫苗临床试验设计和实施的一些具体问题。
