Naxitamab: First Approval

Naxitamab (DANYELZA(R), naxitamab-gqgk) is a humanised (IgG1) anti-GD2 (hu3F8) monoclonal antibody was developed by the Memorial Sloan Kettering Cancer Center (with commercial rights licenced to Y-mAbs therapeutics Inc.) for the treatment of neuroblastoma, osteosarcoma and other GD2-positive cancers. Naxitamab was recently granted accelerated approval by the US FDA for marketing as treatment (in combination with granulocyte-macrophage colony-stimulating factor) for paediatric patients at least one year of age and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow demonstrating a partial response, minor response, or stable disease to prior therapy. This article summarizes the milestones in the development of naxitamab leading to this first approval.

Automated summary

Naxitamab is a humanised anti-GD2 monoclonal antibody developed for the treatment of neuroblastoma and other GD2-positive cancers, which has recently received accelerated approval from the US FDA. This antibody, in combination with a cell-stimulating factor, demonstrates therapeutic effects in patients with partial response, minor response, or stable disease.