The CAR-T treatment Yescarta, known as 'living cancer medicine' and 'cancer cell chain destroyer', has received domestic approval. The Ministry of Food and Drug Safety announced on the 13th that it has approved Yescarta (active ingredient axicabtagene ciloleucel) for patients with blood cancer known as B-cell lymphoma.
CAR-T therapy is a cell-based gene therapy that involves extracting immune T cells from cancer patients' blood, adding genes to enable them to recognize cancer cells, and then killing specific cancer cells. CAR stands for 'chimeric antigen receptor'. It implies that, like the animal chimera from Greek mythology with various animal forms, the immune T cells have genes that enable them to detect the antigen proteins on the surface of cancer cells.
Yescarta was developed by Gilead Sciences in the United States and received approval from the U.S. Food and Drug Administration (FDA) in October 2017. Genetic information was inserted into the patient's T cells to recognize the protein CD19 from cancerous B cells. Once administered to the patient, it recognizes and attacks the CD19-expressing cancer cells.
The Ministry of Food and Drug Safety stated, 'This approval is expected to provide new treatment options for adult patients with diffuse large B-cell lymphoma (DLBCL) who do not respond to existing cancer therapies, and also offer treatment opportunities for patients with primary mediastinal B-cell lymphoma (PMBCL), for which there are no approved treatments in Korea.'
Yescarta is subject to long-term tracking studies under the Advanced Regenerative Medicine and Advanced Therapy Act, and the pharmaceutical company is expected to track adverse events for 15 years from the date of administration.
With the approval of Yescarta, the number of CAR-T treatments that have obtained domestic approval has increased to three. Previously, Novartis' Kymriah and Janssen's Carvykti had received approval from the Ministry of Food and Drug Safety.
However, Carvykti is not yet available in Korea. This is due to foreign pharmaceutical companies delaying supply. CAR-T cells can only be produced when patients go to specialized facilities, which involves significant time and expense. The same supply issues are occurring in the United States.