Friends of Cancer Research, Washington, DC, USA.
Lyell Immunopharma, San Francisco, California, USA.
Cytotherapy. 2020 May;22(5):239-246. doi: 10.1016/j.jcyt.2020.01.014. Epub 2020 Mar 18.
The field of cell therapy is rapidly emerging as a priority area for oncology research and drug development. Currently, two chimeric antigen receptor T-cell therapies are approved by the US Food and Drug Administration and other agencies worldwide for two types of hematologic cancers. To facilitate the development of these therapies for patients with life-threatening cancers with limited or no therapeutic options, science- and risk-based approaches will be critical to mitigating and balancing any potential risk associated with either early clinical research or more flexible manufacturing paradigms. Friends of Cancer Research and the Parker Institute for Cancer Immunotherapy convened an expert group of stakeholders to develop specific strategies and proposals for regulatory opportunities to accelerate the development of cell therapies as promising new therapeutics. This meeting took place in Washington, DC on May 17, 2019. As academia and industry expand research efforts and cellular product development pipelines, this report summarizes opportunities to accelerate entry into the clinic for exploratory studies and optimization of cell products through manufacturing improvements for these promising new therapies.
细胞治疗领域正迅速成为肿瘤学研究和药物开发的重点领域。目前，两种嵌合抗原受体 T 细胞疗法已获得美国食品和药物管理局以及全球其他机构批准，用于两种血液系统癌症。为了促进这些疗法在患有危及生命的癌症且治疗选择有限或没有治疗选择的患者中的应用，基于科学和风险的方法对于减轻和平衡与早期临床研究或更灵活的制造模式相关的任何潜在风险至关重要。癌症研究之友和帕克癌症免疫治疗研究所召集了一组利益相关者专家组，制定了监管机会的具体策略和提案，以加速细胞疗法作为有前途的新疗法的开发。此次会议于 2019 年 5 月 17 日在华盛顿特区举行。随着学术界和工业界扩大研究努力和细胞产品开发管道，本报告总结了通过制造改进为这些有前途的新疗法优化细胞产品并加速探索性研究进入临床的机会。
