Gilead Sciences "Aggressive Lymphoma Diagnostic Treatment Approved by MFDS"

[Financial News] Gilead Sciences Korea and its subsidiary Kite announced on the 18th that 'Yescarta' has been approved by the Ministry of Food and Drug Safety (MFDS) as a treatment for relapsed or refractory B-cell lymphoma.
Yescarta is a chimeric antigen receptor T-cell (CAR-T) therapy. It involves extracting T-cells involved in the patient's immune system, genetically modifying them to target the protein 'CD19' on the surface of cancer cells, and then reintroducing them into the patient. It has been approved as a treatment for adult patients with diffuse large B-cell lymphoma (DCBCL) who relapse or are refractory within 12 months after first-line chemoimmunotherapy, or who relapse or are refractory after second-line or higher systemic therapy, and for adult patients with primary mediastinal V-cell lymphoma.
DCBCL occurs when white blood cells grow abnormally in the body, leading to non-Hodgkin lymphoma. It accounts for 40% of non-Hodgkin lymphoma cases and is commonly found in older adults. With the rapid aging of the population, the number of patients in Korea last year recorded 14,636, doubling in 10 years.
The existing standard treatment for DCBCL was a multi-step process starting with chemoimmunotherapy, followed by high-dose chemotherapy and hematopoietic stem cell transplantation. Only 60% of new large B-cell lymphoma (LBCL) patients respond to initial treatment, while 40% relapse or do not respond, necessitating a second treatment option.
This approval was based on the Phase 3 ZUMA-7 trial comparing CAR-T cell therapy with standard treatment in the patient group. 
Choi Jae-yeon, CEO of Gilead Sciences Korea, stated, "This approval offers a survival possibility to patients diagnosed with aggressive lymphoma and experiencing anxiety," adding, "We will continue to advance the cancer treatment paradigm and strive to deliver the benefits of CAR-T cell therapy to more patients."kaya@fnnews.com Choi Hye-rim Reporter