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DANYELZA
DANYELZA is a monoclonal antibody that targets GD2, a glycolipid antigen expressed on neuroblastoma cells, enabling immune-mediated tumor cell destruction.
DANYELZA is a monoclonal antibody that targets GD2, a glycolipid antigen expressed on neuroblastoma cells, enabling immune-mediated tumor cell destruction. Used for Relapsed or refractory high-risk neuroblastoma (in combination with GM-CSF).
At a glance
| Generic name | DANYELZA |
|---|---|
| Also known as | Naxitamab |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Drug class | GD2-targeting monoclonal antibody |
| Target | GD2 (disialoganglioside) |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
DANYELZA (naxitamab) binds to GD2 on the surface of neuroblastoma cells, marking them for destruction by the immune system through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). It is typically used in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) to enhance immune activation and tumor cell killing.
Approved indications
- Relapsed or refractory high-risk neuroblastoma (in combination with GM-CSF)
Common side effects
- Pain
- Fever
- Infusion reactions
- Neuropathy
- Anemia
- Thrombocytopenia
Key clinical trials
- Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma (PHASE2)
- N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma (PHASE2)
- Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma (PHASE2)
- Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells With or Without Naxitamab (Danyelza) for the Treatment of Patients With Metastatic, GD2 Expressing, HER2 Negative Breast Cancer (PHASE1, PHASE2)
- To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- DANYELZA CI brief — competitive landscape report
- DANYELZA updates RSS · CI watch RSS
- Memorial Sloan Kettering Cancer Center portfolio CI