[Health Korea News / Chang-yong Lee, Seoul, South Korea] Korea's first CAR-T cell therapy, 'Limkato (ingredient: anbalcabtagene autoleucel)', has cleared a key reimbursement milestone, bringing the innovative cancer treatment one step closer to coverage under South Korea's national health insurance system.

Limkato Reaches First Major Reimbursement Milestone

The Health Insurance Review & Assessment Service (HIRA) announced on July 8 that Limkato, developed by Curocell, received reimbursement criteria approval at the 6th meeting of the 2026 Cancer Disease Review Committee (CDRC).

The decision came approximately 40 days after the previous CDRC meeting held on May 27, when the reimbursement criteria review for Limkato was not approved.

The CDRC approved reimbursement criteria for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) following two or more prior systemic therapies.

Limkato Advances Toward National Insurance Listing

Following the CDRC decision, Limkato will proceed through additional reimbursement procedures, including review by HIRA's Drug Reimbursement Evaluation Committee, price negotiations with the National Health Insurance Service, and final deliberation by the Health Insurance Policy Review Committee under the Ministry of Health and Welfare.

If the remaining procedures proceed smoothly, Limkato could be officially listed for reimbursement as early as the second half of 2026.

Industry observers expect the process to move faster, as Limkato was selected for the government's pilot program designed to allow parallel progress of regulatory approval, reimbursement assessment, and pricing negotiations. Some industry sources predict that national health insurance coverage could begin as early as September.

Other Cancer Drug Reimbursement Decisions

In addition to Limkato, the CDRC also approved reimbursement criteria expansion for a combination chemotherapy regimen consisting of dexamethasone, cyclophosphamide, etoposide, and cisplatin (DCEP) for patients with relapsed or refractory multiple myeloma.

Meanwhile, the committee postponed a final decision on Roche Korea's 'Perjeta Inj (ingredient: pertuzumab)', a HER2-positive breast cancer treatment, and decided to conduct a further review.

Roche Korea had applied for reimbursement expansion of Perjeta in combination with trastuzumab and chemotherapy as neoadjuvant therapy for patients with HER2-positive breast cancer, including those with locally advanced, inflammatory, or early-stage disease with tumors larger than 2 cm. However, the application did not receive approval at the latest review meeting.