Korea Food and Drug Administration, Novartis Immunity Cancer Drug Approved in Korea… No. 1 advanced biopharmaceutical

Input 2021.03.05 13:08

CAR-T cell therapy’Kimria’–

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The Ministry of Food and Drug Safety announced on the 5th that it had approved the domestic market of’Kimriaju’, an immune cell (CAR-T cell) anticancer drug from Novartis, a multinational pharmaceutical company.

CAR-T cells are genetically modified so that T cells, which are immune cells, can better attack cancer cells. This treatment was approved after being designated as a’breakthrough designation’ in the US and a’priority medicine’ (PRIME) in Europe.

This treatment is used in the treatment of patients with relapsed and refractory B-cell acute lymphocytic leukemia under the age of 25 and adult patients with diffuse large B-cell lymphoma.

This treatment is the first’advanced biopharmaceutical’ designated under the’Advanced Regenerative Bio Act’. According to the relevant law, the status of abnormal cases must be followed for a long period of time for 15 years from the date of administration, and the tracking contents and results must be reported to the Ministry of Food and Drug Safety on a regular basis every year from the date of initial sale.

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