Curocell announced on Sept. 4 that its chimeric antigen receptor T-cell (CAR-T) therapy Rimqarto (generic name: anbalcabtagene autoleucel) was deemed eligible for national health insurance coverage during the ninth Drug Reimbursement Evaluation Committee meeting hosted by the Health Insurance Review & Assessment Service (HIRA) on Sept. 3, conditional on the company accepting the assessed price.
Rimqarto previously cleared HIRA's Cancer Disease Review Committee, which evaluates reimbursement criteria, in July. To secure full coverage, the drug will next undergo price negotiations with the National Health Insurance Service (NHIS) and a review by the Health Insurance Policy Deliberation Committee, before official coverage is enacted via a Ministry of Health and Welfare notification.
Rimqarto is the first CAR-T therapy developed in South Korea for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL) who have failed two or more prior lines of systemic therapy.
In a Phase 2 clinical trial evaluated by an Independent Review Committee (IRC) independent of the company and clinical investigators, Rimqarto achieved an objective response rate (ORR) of 75.3% and a complete response (CR) rate of 67.1%. ORR represents the proportion of patients whose tumors shrink past a specified threshold, while CR denotes patients whose cancer becomes undetectable on diagnostic testing.
The therapy also demonstrated a manageable safety profile, recording an 8.9% incidence of grade 3 or higher cytokine release syndrome (CRS) and a 3.8% incidence of high-grade neurotoxicity. Cytokine release syndrome is an inflammatory response—often marked by fever, low blood pressure, and shortness of breath—that occurs when immune cells are rapidly activated following CAR-T infusion.
Rimqarto’s clinical trial findings were published in Blood, the flagship international medical journal of the American Society of Hematology (ASH).
Rimqarto is manufactured and supplied directly as a finished pharmaceutical product at Curocell's domestic Good Manufacturing Practice (GMP) facility. Even if a hospital lacks a dedicated cell-processing center, medical staff can collect a patient’s T cells and ship them to Curocell for manufacturing. This setup is expected to enable prompt treatment at regional medical centers that previously struggled to deliver CAR-T therapies due to infrastructure constraints.
Kim Gun-soo, CEO of Curocell, said, “As soon as we receive official notification of HIRA’s detailed review results, we will conduct an internal review and respond carefully. We will do our utmost throughout the remaining procedures so that Rimqarto, which has demonstrated outstanding efficacy and safety, can be delivered quickly to domestic patients with relapsed or refractory blood cancers.”
