A pharmacological and clinical profile of Naxitamab for the treatment of high-risk neuroblastoma.
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INTRODUCTION: Naxitamab (previously named hu3F8) is a humanized monoclonal antibody (mAb) targeting disialoganglioside GD2, a ganglioside homogeneously and abundantly expressed on neuroblastoma and other neuroectodermal tumors. Anti-GD2 mAbs are an integral part of the standard therapeutic paradigm for high-risk neuroblastoma. Naxitamab, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), is approved by regulatory authorities for patients with relapsed or refractory neuroblastoma in the bone and/or bone marrow. AREAS COVERED: This review provides a comprehensive overview of the preclinical development, clinical efficacy, and safety profile of naxitamab. It summarizes and discusses the key clinical trials, real-world experiences, and adverse events management. EXPERT OPINION: Naxitamab has shown a favorable toxicity profile and meaningful therapeutic efficacy in relapsed or refractory diseases and as consolidation therapy in high-risk neuroblastoma. Ongoing clinical studies and expanded global use continue to evaluate its safety and efficacy, to optimize its integration with standard care, and to fully exploit its therapeutic potential. Advances in protein engineering can further extend the utility of anti-GD2 mAbs, enabling the creation of radioimmunoconjugates, novel bispecific antibodies, and pre-targeting strategies, offering potent tumor selectivity while mitigating off-target toxicity.