BLAINTRAVENOUSSOLUTIONPriority Review
Approved
Nov 2020
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
5/8 — Partial
Priority Review
DANYELZA (naxitamab) by Y-mAbs Therapeutics is glycolipid disialoganglioside-directed antibody interactions [moa]. Approved for neuroblastoma. First approved in 2020.
Drug data last refreshed 20h ago
Mechanism of Action
Glycolipid Disialoganglioside-directed Antibody Interactions
Pharmacologic Class:
Glycolipid Disialoganglioside-directed Antibody
Indications (1)
Clinical Trials (8)
Patients Between the Ages of 12 Months to 21 Years With Newly-Diagnosed High-Risk Neuroblastoma Will Receive Children's Oncology Group (COG) Type Recommended Therapy With the Addition of Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) to Induction Cycles 1-5
Started May 2026
10 enrolled
High-Risk Neuroblastoma
Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)
Started Sep 2025
31 enrolled
Metastatic Triple-Negative Breast Cancer
Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma
Started Jun 2025
18 enrolled
NeuroblastomaNeuroblastoma RecurrentRelapsed Neuroblastoma+1 more
Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response.
Started Oct 2023
62 enrolled
Neuroblastoma
Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
Started Sep 2022
93 enrolled
Neuroblastoma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.