Naxitamab: First Approval

Drugs. 2021 Feb;81(2):291-296. doi: 10.1007/s40265-021-01467-4.


Naxitamab (DANYELZA®, 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.

Publication types

  • Review

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Child
  • Glycolipids / therapeutic use*
  • Humans
  • Neuroblastoma / drug therapy*
  • Osteosarcoma / drug therapy*
  • United States
  • United States Food and Drug Administration


  • Antibodies, Monoclonal, Humanized
  • Glycolipids
  • naxitamab-gqgk