Registering the first CAR-T technologies: useful experience for Russia

Abstract

Chimeric Antigen Receptor T-Cell therapy (CAR-T) is an advanced approach to the treatment of cancer. In foreign practice, CAR-T drugs belong to regulatory group of advanced medications. These drugs are much more difficult to be developed compared with other more traditional medications due to their cellular and genetic nature. Initial clinical trials of CAR-T showed encouraging results in the treatment of cancer. Two CAR-T drugs (Kymriah and Yescarta) have been already approved for administration in the United States and Europe. This review is devoted to the current practice of registering CAR-T drugs as a special class of advanced medications by FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) including the process of approval and specific regulatory tools. Moreover, important future trends in this area have been identified.