South Korea’s Ministry of Food and Drug Safety has granted full regulatory approval to Rimqarto (anbalcabtagene autoleucel), making Curocell the first Korean company to commercialize a CAR-T cell therapy. The approval covers adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or primary mediastinal large B-cell lymphoma (PMBCL) who have received two or more prior lines of systemic therapy.
The MFDS granted full approval rather than conditional approval, waiving the requirement for Phase III trial data given the therapy’s classification as a novel CAR-T product and its use in a third-line treatment setting. The approval is nonetheless subject to long-term follow-up studies and risk management protocols to monitor ongoing safety and efficacy, consistent with the regulatory framework applied to other approved CAR-T therapies globally. Rimqarto also becomes the 42nd drug approved for manufacture and sale under South Korea’s Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products.
The therapy is an autologous CD19-directed CAR-T product built on Curocell’s proprietary OVIS (Overcome Immune Suppression) platform, which is designed to attenuate immunosuppressive signaling within the tumor microenvironment and address T-cell exhaustion — a recognized limitation of first-generation CAR-T approaches.
The pivotal Phase II trial supporting the approval reported an objective response rate of 75.3% and a complete response rate of 67.1% in adult patients with relapsed or refractory DLBCL and PMBCL. On the safety side, cytokine release syndrome was reported in 10% of patients, and immune effector cell-associated neurotoxicity syndrome in 5%. No trial registry identifier was included in the available source material. The MFDS’s decision to grant full rather than conditional approval on the basis of this Phase II dataset reflects a regulatory judgment about the robustness of the data in the context of a third-line indication with limited alternatives.
The approval places Rimqarto in a competitive landscape that already includes Yescarta (axicabtagene ciloleucel), developed by Kite Pharma and marketed by Gilead Sciences, and Breyanzi (lisocabtagene maraleucel), developed by Juno Therapeutics and marketed by Bristol Myers Squibb — both CD19-directed autologous CAR-T therapies approved in the US, Europe, and South Korea for the same third-line DLBCL and PMBCL population. Curocell has stated plans to pursue indication expansion and global market entry, as well as extension of its CAR-T platform into solid tumors and autoimmune diseases, though no registered trials in those areas were identified in the available source material.
This article was generated with AI assistance and reviewed and edited by the AllSci editorial team
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