The Ministry of Health and Welfare said Friday that a treatment plan for patients with rare lymphoma at high risk of recurrence has been approved as the first advanced regenerative medicine treatment since the system was implemented.
The Catholic University of Korea Yeouido St. Mary’s Hospital submitted the plan.
The Catholic University of Korea Yeouido St. Mary’s Hospital in Seoul (Courtesy of the hospital)
The newly approved treatment is designed for patients with Epstein–Barr virus (EBV)-positive extranodal natural killer/T-cell lymphoma (ENKL) who have achieved complete remission after anticancer therapy but remain at high risk of relapse. The plan involves administering autologous EBV antigen-specific immune cells (T cells) derived from the patient.
Despite the availability of chemotherapy and radiation, the disease remains challenging to treat, with high recurrence rates leading to a significant increase in mortality following relapse.
This urgent need for innovative therapies underscores the goal of preventing recurrence and extending long-term disease-free survival for affected patients.
Given the strong association between ENKL and EBV, this targeted immunotherapy seeks to eradicate residual cancer cells in high-risk patients, directly addressing relapse and striving to enhance survival outcomes beyond standard treatments.
This first approved case was submitted through a government-initiated regulatory sandbox program that grants special provisions allowing treatment plans to be reviewed based on results from commercial clinical trials.
The application was based on phase 2 clinical trial data. Following approval by the review committee, the plan will be submitted to the Industrial Convergence Regulatory Special Review Committee, where a decision on granting regulatory exemptions will be made before the treatment is implemented.
Costs directly associated with the advanced regenerative treatment—such as cell collection, processing, and administration—will not be covered by insurance. However, other medical expenses incurred during lymphoma treatment, including diagnostic tests and clinical care, will be eligible for coverage under the national health insurance system in accordance with standard reimbursement criteria.
Kim Hyun-sook, director general for Advanced Medical Support at the Health Ministry, emphasized, “This historic approval offers transformative hope to patients with rare lymphoma at significant risk of recurrence.”
Kim added, “This first approval is significant in that it marks the beginning of the advanced regenerative medicine treatment system in real-world clinical practice. We will continue to strengthen institutional support, including system improvements, to ensure that such treatments can be implemented smoothly in response to unmet medical needs.”
Kwak Sung-sun
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