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KMID : 1142220220170010045
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Regulatory Research on Food, Drug & Cosmetic
2022 Volume.17 No. 1 p.45 ~ p.55
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Case Study of CAR-T Cell·Gene Therapy Approval Data
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Kim Yu-Na
Hwang Chae-Won
Jeon Bo-Gyeong
Han Da-Hye
Jin Da-Young
Lee Chang-Jae
Choi Yoon-Jeong
Lee Sang-Hyo
Kwon Kyeng-Hee
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Abstract
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CAR-T treatment is an immune cell therapy anticancer drug prepared by combining genetic information that expresses cancer cell-specific chimeric antigen receptors in the patient's T cells. CAR-T cells were redesigned like the Chimera inserting new genes so that normal T cells could actively detect and destroy specific parts of cancer cells. CAR-T treatment is different from existing anticancer drugs in that it uses immune cells in the body rather than external substances to kill cancer cells, so they were named ‘chimeric antigen receptor T cells’ (CAR-T). CAR-T treatment is the fourth-generation immuno-cancer drug, and clinical trials with various diseases as indications are actively underway. Overseas, a total of six CAR-T treatments, including Janssen Biotech's Carvykti, which obtained permission on February 28, 2022 with multiple myeloma as an indication, obtained FDA approval, and EMA also has granted a conditional approval for Jansen Biotech's Carvykti on May 26, 2022. In Korea, Novartis's Kymriah obtained an approval from MFDS on March 5, 2021, and many domestic pharmaceutical companies such as GC Cell, Curocell, and AbClon are currently conducting clinical trials on CART treatments. In the case of cell·gene therapy products such as CAR-T treatments, the submission data at the time of approval is different compared to the existing chemotherapy due to the characteristics of the drug. In this study, six types of FDA-approved CAR-T treatments were analyzed based on the permission data of Carvykti, the most recently approved CAR-T treatment by the FDA, and it is hoped that this article will help domestic CAR-T treatment developers prepare.
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KEYWORD
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Drug, Cell gene therapy, CAR-T, Anticancer drug
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