Providing new treatment opportunities for patients with recurrent and refractory hematologic cancer without alternative drugs
Kimria, a method of introducing genetic information to the surface of immune cells (T cells) collected from patients and then injecting them
It can provide new treatment opportunities for patients with recurrent refractory blood cancer.
According to the Ministry of Food and Drug Safety on the 5th, the world’s first chimeric antigen receptor T-cell (CAR-T) treatment’Kimriaju (Tisagen Lexyucell)’ was approved as the first high-tech biopharmaceutical. Kimliaju has applied for permission as a gene therapy product among advanced biopharmaceuticals by Novartis Korea.
Advanced biopharmaceuticals are drugs made from living cell tissues or genetic materials, such as cell therapy products and gene therapy products, and were implemented in August of last year to support differentiated safety management and productization tailored to the characteristics of advanced biopharmaceuticals.
Kimlia is a breakthrough designation drug in the US and a priority drug in Europe, as an innovative immune cell anticancer drug that has clearly shown improved benefits in a single administration to patients with recurrent refractory hematologic cancer who have limited choice of other treatments. It has been approved after being designated as (PRIME).
Relapsed or secondary relapse after transplantation and subsequent relapsed or refractory B cells in children and young adult patients under 25 years of age and relapsed refractory diffuse giant B cells after treatment of acute lymphocytic leukemia and two or more systemic treatments. It is known to be effective and effective in the treatment of adult patients with lymphoma (DLBCL).
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.
Chimeric antigen receptor (CAR) T cells are 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, and specifically recognizes the surface antigens of cancer cells. It is a cell that has a function to honor.
For CAR-T, a vector containing a single chain Fv (scFv) transgene is prepared in step 1, a vector is introduced into T cells in step 2, and T cell proliferation and administration with a chimeric antigen receptor gene introduced in step 3 are performed.
This drug is a drug subject to long-term follow-up investigation pursuant to Article 30 of the Advanced Regenerative Bio Act, and should be followed for 15 years from the date of administration for abnormal cases. You must report.
An official from the Ministry of Food and Drug Safety expected that “the approval of this product will provide a new treatment opportunity for patients with recurrent refractory hematologic cancer who do not have an alternative drug or have not established a standard treatment method.”
Chemistry is everywhere. Copyright © Chemical News Unauthorized reproduction and redistribution prohibited