Kunos Charles A, Capala Jacek, Ivy Susan Percy
Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, United States.
Radiation Research Program, National Cancer Institute, Bethesda, MD, United States.
Front Oncol. 2019 Jun 28;9:573. doi: 10.3389/fonc.2019.00573. eCollection 2019.
Targeted radiopharmaceutical conjugates intended for therapeutic use often are made of three key components, a decaying radionuclide, a chemical chelator/linker, and a targeted molecular entity. The National Cancer Institute (NCI) Experimental Therapeutics Program has accepted four radiopharmaceutical drug products so far that fit the targeted radiopharmaceutical conjugate class. As the NCI sharpens its thinking about its role as an investigational new drug sponsor for radiopharmaceuticals in clinical development, it has considered the relative merits of modular radiopharmaceutical drug master files. Here, the NCI provides its perspective on modular radiopharmaceutical drug master files as it initiates a clinical development program for such agents and further organizes its radiopharmaceutical Small Business Innovation Research portfolio.
一个衰变的放射性核素、一个化学螯合剂/连接体以及一个靶向分子实体。美国国家癌症研究所（NCI）的实验治疗计划迄今已接受了四种符合靶向放射性药物偶联物类别的放射性药物产品。随着NCI对其作为临床开发中放射性药物研究新药申办者的角色思考更加深入，它已考虑了模块化放射性药物主文件的相对优点。在此，NCI在启动此类药物的临床开发计划并进一步组织其放射性药物小企业创新研究组合时，提供了其对模块化放射性药物主文件的看法。
