Korea Food and Drug Administration, Novartis CAR-T anticancer drug’Kimria’ approved in Korea

The Ministry of Food and Drug Safety has approved the world’s first chimeric antigen receptor T-cell (CAR-T) treatment’Kimriaju (Tisagen Rexel)’, which Novartis Korea applied for permission, as the first advanced biopharmaceutical under the Advanced Regenerative Bio Act Sun said.

Advanced biopharmaceuticals refer to drugs made from living cells, tissues, or genetic materials such as cell therapy products and gene therapy products. ‘Chimeric Antigen Receptor (CAR) T Cell’ is a gene that combines the receptor site of immune cells (T cells) and the antigen recognition site of cancer cells into the patient’s T cells, and specifically recognizes the surface antigens of cancer cells. It is a cell that has an attacking function.

Kimliaju, an anticancer drug developed by Novartis, treats cancer by introducing genetic information to the surface of immune cells (T cells) collected from patients to recognize specific antigens of cancer cells, and then injecting them into the patient’s body. This drug has been designated as a breakthrough drug in the United States and a priority drug in Europe, as it has the effect of improving the condition when administered once to patients with relapsed and refractory hematologic cancer, where the choice of other treatments is limited.

The Ministry of Food and Drug Safety said, “We expect that the approval of this product will provide new treatment opportunities for patients with recurrent and refractory blood cancer who do not have alternative drugs or for whom standard treatment methods have not been established.” “We will safely manage from the cell collection to the post-use stage.”

[박윤균 기자]
[ⓒ 매일경제 & mk.co.kr, 무단전재 및 재배포 금지]

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