[KJA뉴스통신] Chimeric antigen receptor T cell anticancer drug’Kimria’ approved in Korea

[KJA뉴스통신] The Ministry of Food and Drug Safety has approved the world’s first chimeric antigen receptor T-cell therapy’Kimria’, which was applied for permission by Novartis Korea, as the first advanced biopharmaceutical under the’Advanced Regenerative Bio Act.

The’chimeric antigen receptor T cell’ is a gene that combines the receptor site of immune cells and the characteristic antigen recognition site on the surface of cancer cells into the patient’s T cells. It is a cell.

‘Kimria’ is an anticancer drug in which genetic information is introduced into the patient’s body so that specific antigens of cancer cells can be recognized on the surface of immune cells collected from patients.

This drug is an innovative immune cell anticancer drug that showed clearly improved benefits with a single administration to patients with relapsed and refractory hematologic cancer1) who have limited choice of other treatments.It is a breakthrough drug in the United States and a priority drug in Europe, respectively. After designation, permission2) was obtained.

The Ministry of Food and Drug Safety has thoroughly scientifically reviewed and evaluated the quality, safety and effectiveness, and post-marketing safety management plan, etc. of the applied drug according to the review criteria of the’Advanced Renewable Bio Act’ The Central Pharmacy Review Committee consulted on the validity of the product’s approval and conformity to the system.

In particular, this drug is a drug subject to a’long-term follow-up investigation’ pursuant to Article 30 of the’Advanced Renewable Bio Act’, and the status of abnormal cases must be tracked for 15 years from the date of administration. Etc. must be reported to the Ministry of Food and Drug Safety.

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 hematologic 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.”