S. Korea approves first domestically developed CAR-T cancer therapy

(Ministry of Food and Drug Safety)

The Ministry of Food and Drug Safety said Wednesday it has approved the country’s first locally developed CAR-T cancer therapy, marking a milestone in South Korea’s advanced biopharmaceutical sector.

The therapy, Limkato, developed by Curocell, is a personalized gene-based treatment that modifies a patient’s immune cells to target and destroy cancer cells more precisely.

It is indicated for adult patients with relapsed or refractory diffuse large B-cell lymphoma and primary mediastinal B-cell lymphoma who have undergone at least two prior lines of systemic treatment.

CAR-T therapies have until now relied on imported products costing hundreds of millions of won per treatment. The approval of a domestically developed therapy is expected to improve access and provide more stable treatment options for patients with limited alternatives.

The regulator said it will continue to support the rapid introduction of safe and effective treatments for life-threatening and rare diseases, expanding access for patients through its regulatory science expertise.