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Hu3F8 (NAXITAMAB)
Hu3F8 works by binding to a specific glycolipid on cancer cells, marking them for destruction by the immune system.
Naxitamab (Hu3F8), marketed by Y-Mabs Therapeutics Inc., is a targeted antibody therapy for relapsed or refractory high-risk neuroblastoma, a niche but critical oncology indication. Its key strength lies in its unique mechanism of action, which binds to a specific glycolipid on cancer cells, effectively marking them for immune system destruction, setting it apart from other same-class competitors such as gemtuzumab ozogamicin and ipilimumab. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generic or biosimilar products.
At a glance
| Generic name | NAXITAMAB |
|---|---|
| Sponsor | Y-Mabs Therapeutics Inc |
| Drug class | Glycolipid Disialoganglioside-directed Antibody [EPC] |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2020 |
Mechanism of action
Naxitamab-gqgk binds to the glycolipid GD2. GD2 is disialoganglioside that is overexpressed on neuroblastoma cells and other cells of neuroectodermal origin, including the central nervous system and peripheral nerves. In vitro, naxitamab-gqgk was able to bind to cell surface GD2 and induce complement dependent cytotoxicity (CDC) and antibody dependent cell-mediated cytotoxicity (ADCC).
Approved indications
- Relapsed or Refractory High-Risk Neuroblastoma
Boxed warnings
- WARNING: SERIOUS INFUSION-RELATED REACTIONS and NEUROTOXICITY WARNING: SERIOUS INFUSION-RELATED REACTIONS and NEUROTOXICITY See full prescribing information for complete boxed warning Serious Infusion-Related Reactions: DANYELZA can cause serious infusion reactions, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor. Premedicate prior to each DANYELZA infusion as recommended. Reduce the rate, interrupt infusion, or permanently discontinue DANYELZA based on severity ( 2.2 , 2.3 , 4 , 5.1 ). Neurotoxicity: DANYELZA can cause severe neurotoxicity, including severe neuropathic pain, transverse myelitis, and reversible posterior leukoencephalopathy syndrome (RPLS). Premedicate to treat neuropathic pain as recommended. Permanently discontinue DANYELZA based on the adverse reaction and severity ( 2.2 , 2.3 , 5.2 ). Serious Infusion-Related Reactions DANYELZA can cause serious infusion reactions, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor. Infusion reactions of any Grade occurred in 94-100% of patients. Severe infusion reactions occurred in 32-68% and serious infusion reactions occurred in 4 - 18% of patients in DANYELZA clinical studies [see Warnings and Precautions (5.1) ]. Premedicate prior to each DANYELZA infusion as recommended and monitor patients for at least 2 hours following completion of each infusion. Reduce the rate, interrupt infusion, or permanently discontinue DANYELZA based on severity [see Dosage and Administration (2.2 , 2.3) , Contraindications (4) , and Warnings and Precautions (5.1) ]. Neurotoxicity DANYELZA can cause severe neurotoxicity, including severe neuropathic pain, transverse myelitis and reversible posterior leukoencephalopathy syndrome (RPLS). Pain of any Grade occurred in 94-100% of patients in DANYELZA clinical studies [see Warnings and Precautions (5.2) ]. Premedicate to treat neuropathic pain as recommended. Permanently discontinue DANYELZA based on the adverse reaction and severity [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.2) ].
Common side effects
- infusion-related reaction
- pain
- tachycardia
- vomiting
- cough
- nausea
- diarrhea
- decreased appetite
- hypertension
- fatigue
- erythema multiforme
- peripheral neuropathy
Key clinical trials
- Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma (PHASE2)
- Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow (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)
- Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma (PHASE1,PHASE2)
- Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC) (PHASE1,PHASE2)
- A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma (PHASE2)
- Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Hu3F8 CI brief — competitive landscape report
- Hu3F8 updates RSS · CI watch RSS
- Y-Mabs Therapeutics Inc portfolio CI