[서울=뉴스핌] Reporter Jeong Seung-won = The Ministry of Food and Drug Safety has approved the world’s first chimeric antigen receptor T-cell (CAR-T) treatment Kimria (Tisagen Lexucell), which was applied for permission by Novartis Korea, as the first high-tech biopharmaceutical under the Advanced Regenerative Bio Act. It was revealed on the 5th.
Chimeric antigen receptor T cells are a gene that combines the receptor site of immune cells (T cells) and the characteristic antigen recognition site on the surface of cancer cells into the patient’s T cells. It has the ability to recognize and attack.
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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 (T cells) collected from patients.
This drug is a breakthrough designation drug in the US and a priority drug in Europe, as an innovative immune cell anti-cancer drug that showed clearly improved benefits in a single administration to patients with relapsed and refractory hematologic cancer, where the choice of other treatments was limited. After being designated as (PRIME), they received permission.
The Ministry of Food and Drug Safety has thoroughly scientifically reviewed and evaluated the quality, safety and effectiveness, and post-marketing safety management plan for the applied drug in accordance with the review criteria of the Advanced Regenerative Bio Act, and the Central Pharmacy Review Committee, which includes medical experts in the field of blood cancer. At the same time, we consulted on the validity of the product’s license and conformity to the system.
This drug is a drug subject to long-term follow-up investigation pursuant to Article 30 of the Advanced Regenerative Bio Act.The status of abnormal cases must be followed for 15 years from the date of administration, and the contents and results of the long-term follow-up investigation every year from the date of initial sale are reported to the Ministry of Food and Drug Safety. You must report.
An official from the Ministry of Food and Drug Safety said, “We expect that the approval of this product will provide new treatment opportunities for patients with relapsed and refractory hematologic cancer who do not have an alternative drug or a standard treatment method has not been established.” “We will safely manage from the cell collection to the post-use stage.”
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