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Omelyanovskiy V.V.

Center for Expertise and Quality Control of Medical Care;
Russian Medical Academy of Continuous Professional Education;
Research Financial Institute;
Semashko National Research Institute of Public Health

Bezdenezhnykh T.P.

Center for Expertise and Quality Control of Medical Care;
Financial Research Institute

Teptsova T.S.

Center for Expertise and Quality Control of Medical Care;
I.M. Sechenov First Moscow State Medical University (Sechenov University)

Musina N.Z.

Center for Expertise and Quality Control of Medical Care;
St. Petersburg State Chemical Pharmaceutical University;
Russian Presidential Academy of National Economy and Public Administration

Melnikova L.S.

Center for Expertise and Quality Control of Medical Care;
Financial Research Institute

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

Authors:

Omelyanovskiy V.V., Bezdenezhnykh T.P., Teptsova T.S., Musina N.Z., Melnikova L.S.

More about the authors

Journal: Medical Technologies. Assessment and Choice. 2020;(2): 18‑25

DOI: 10.17116/medtech20204002118

Read: 7384 times

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Table of contents

REGISTERING THE FIRST CAR-T TECHNOLOGIES: USEFUL EXPERIENCE FOR RUSSIA
REGISTERING THE FIRST CAR-T TECHNOLOGIES: USEFUL EXPERIENCE FOR RUSSIA

To cite this article:

Omelyanovskiy VV, Bezdenezhnykh TP, Teptsova TS, Musina NZ, Melnikova LS. Registering the first CAR-T technologies: useful experience for Russia. Medical Technologies. Assessment and Choice. 2020;(2):18‑25. (In Russ.)
https://doi.org/10.17116/medtech20204002118

Подписка 2026 Медицинские технологии. Оценка и выбор (Medical Technologies. Assessment and Choice)
МСФ на ЯМ
Использование инфографики авторами научных работ
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Recommended articles:
Application of T-cells with chimeric anti­gen rece­ptor in the treatment of refractory autoimmune diseases. Russian Journal of Preventive Medi­cine. 2025;(7):106-110
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.

Keywords:

CAR-T-cell therapy
FDA
EMA
Kymriah
Yescarta

Authors:

Omelyanovskiy V.V.

Center for Expertise and Quality Control of Medical Care;
Russian Medical Academy of Continuous Professional Education;
Research Financial Institute;
Semashko National Research Institute of Public Health

Bezdenezhnykh T.P.

Center for Expertise and Quality Control of Medical Care;
Financial Research Institute

Teptsova T.S.

Center for Expertise and Quality Control of Medical Care;
I.M. Sechenov First Moscow State Medical University (Sechenov University)

Musina N.Z.

Center for Expertise and Quality Control of Medical Care;
St. Petersburg State Chemical Pharmaceutical University;
Russian Presidential Academy of National Economy and Public Administration

Melnikova L.S.

Center for Expertise and Quality Control of Medical Care;
Financial Research Institute

Received:

07.05.2020

Accepted:

13.05.2020

Close metadata

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