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These highlights do not include all the information needed to use DANYELZA safely and effectively. See full prescribing information for DANYELZA. DANYELZA® (naxitamab-gqgk) injection, for intravenous use Initial U.S. Approval: 2020
Medication labelWhy this: Advisory · dailymed-prescription
DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- generic_name
- naxitamab
- product_names
- Naxitamab
- ndc
- 73042-201, 73042-201-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en