The Ministry of Food and Drug Safety approved the world’s first chimeric antigen receptor T-cell (CAR-T) treatment’Kimriaju (Tisagen Lexucell)’, which was applied for approval by Novartis Korea on the 5th, as the first advanced biopharmaceutical under the Advanced Regenerative Bio Act did.
Product classification is a gene therapy product among advanced biopharmaceuticals, and the efficacy effect (indication) is ▲ relapse or secondary recurrence after transplantation in children and young adult patients under 25 years of age and subsequent relapse or refractory B-cell acute lymphocytic leukemia ( ALL) treatment ▲ approved for treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more systemic treatments.
The Advanced Regenerative Medicine and Advanced Biopharmaceuticals Safety and Support Act (Advanced Regenerative Bios Act) has been implemented since August last year to support differentiated safety management and commercialization suitable for the characteristics of advanced biopharmaceuticals. It refers to medicines made from living cells, tissues, or genetic materials such as therapeutic agents.
Chimeric antigen receptor T cells are a gene that combines a receptor site of immune cells (T cells) with a characteristic antigen recognition site on the surface of cancer cells into a patient’s T cells. It is a cell that has the function of recognizing and attacking.
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.
It is an innovative immune cell anticancer drug that showed clearly improved benefits in a single administration to patients with relapsed and refractory hematologic cancer, where the choice of other treatments is limited, breakthrough designation in the United States, and priority drugs in Europe ( PRIME), respectively, and obtained permission.
After receiving an application for permission from Novartis, the Ministry of Food and Drug Safety conducted a thorough scientific review and evaluation of the quality, safety and effectiveness, and post-marketing safety management plan of the drug in accordance with the review criteria of the Advanced Regenerative Bio Act.
In addition, the Central Pharmacist Review Committee, which includes experts in the field of hematological cancer, consulted on the validity of the product’s approval and conformity to the system.
The Ministry of Food and Drug Safety said, “In particular, this drug is a drug subject to’long-term follow-up investigation’ pursuant to Article 30 of the Advanced Regenerative Bio Act, and the status of abnormal cases should be followed for a long time for 15 years from the date of administration.” “The contents and results of the long-term follow-up survey must be reported to the Ministry of Food and Drug Safety.”
“This product approval 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 manage it safely until the stage after use,” he said.