Korea approves Gilead’s CAR-T therapy Yescarta for B-cell lymphomas

The Ministry of Food and Drug Safety (MFDS) has approved Gilead Sciences’ chimeric antigen receptor T-cell (CAR-T) therapy Yescarta (ingredient: axicabtagene ciloleucel) for the treatment of relapsed or refractory B-cell lymphomas, expanding advanced cell and gene therapy options in Korea.

Yescarta is a patient-specific therapy using a patient’s own T cells, which are genetically engineered to recognize and destroy cancer cells. The process involves inserting genetic information for a receptor that targets the CD19 surface antigen, a hallmark of malignant B cells. Once reinfused, the modified CAR-T cells detect and kill CD19-expressing tumor cells.

The MFDS authorized Yescarta for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and for patients with primary mediastinal large B-cell lymphoma (PMBCL), a rare subtype recognized as distinct from DLBCL due to its unique clinical and pathological characteristics.

DLBCL is the most common type of non-Hodgkin lymphoma, accounting for about 30 percent of cases, and is known for its aggressive progression. PMBCL, while less common, has similarly limited treatment options in Korea.

Yescarta was reviewed under Korea’s Advanced Regenerative Bio Act, which regulates the safety and oversight of advanced cell and gene therapies.

As a condition of approval, the therapy is classified as a long-term follow-up product under the Act, requiring the manufacturer to monitor adverse events for 15 years from the date of administration.

While Novartis’ Kymriah has been the only CAR-T therapy reimbursed in Korea and has been effectively dominating the local market, globally, however, Yescarta has surpassed Kymriah in both approved indications and sales.

In 2024, Yescarta generated $1.6 billion in global revenue, compared with $443 million for Kymriah and $963 million for Johnson & Johnson Innovative Medicine’s Carvykti.

“Yescarta will provide a new treatment option for adult patients with relapsed or refractory DLBCL, and offer a therapeutic opportunity for PMBCL patients, for whom no approved treatments currently exist in Korea,” the MFDS said.