Drug intelligence / Profile preview

naxitamab

Development stage
Approved
Lead developer
Y-mAbs Therapeutics
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Naxitamab is a humanized IgG1 monoclonal antibody that targets the disialoganglioside GD2, an antigen highly expressed on neuroblastoma and other neuroectodermal tumors. By binding to GD2 on tumor cells, naxitamab directs the immune system to attack these cells through both complement-dependent cytotoxicity and antibody-dependent cellular cytotoxicity. It is primarily indicated for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of relapsed or refractory high-risk neuroblastoma in bone or bone marrow in patients aged one year and older who have shown at least stable disease after prior therapy. Naxitamab was developed as a more convenient alternative to earlier anti-GD2 antibodies, offering outpatient administration and not requiring concurrent interleukin-2 or retinoic acid therapy[2][5][6]. The drug received FDA approval under accelerated review due to its efficacy in this rare pediatric cancer population[5].

Brand names
Danyelza
Other names
naxitamab-gqgk
02

Targets

GD2

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