Last reviewed 2026-06-02 · How we verify

DANYELZA (NAXITAMAB-GQGK)

DANYELZA (generic name: NAXITAMAB-GQGK) is a Glycolipid Disialoganglioside-directed Antibody [EPC] drug developed by Y-MABS THERAPEUTICS INC. It is currently FDA-approved for Neuroblastoma.

Naxitamab-gqgk binds to GD2 on neuroblastoma cells, inducing CDC and ADCC.

Danyelza is a monoclonal antibody that targets disialoganglioside GD2, a molecule found on certain cancer cells. It is being studied in clinical trials for various types of cancer, including anatomic stage IV breast cancer, neuroblastoma, and high-risk neuroblastoma.

At a glance

Mechanism of action

Naxitamab-gqgk targets the GD2 glycolipid, which is overexpressed on neuroblastoma cells. By binding to GD2, it triggers immune responses that lead to the destruction of these cancer cells through complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity.

Approved indications

• 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

Serious adverse events

• Hypertension
• Hypotension
• Anaphylactic reaction
• Pyrexia
• Pain
• Respiratory depression
• RPLS
• Bronchospasm
• Apnea
• Device related infection

Key clinical trials

• Phase 1b/2 Study of Naxitamab (Danyelza), Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells in Advanced GD2-expressing Breast Cancers (DiG NKs) (Phase 1)
• Phase II Trial of Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma (Phase 2)
• A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma (Phase 2)
• N10: Reduced Therapy for High-Risk Neuroblastoma (Phase 2)
• To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Phase 2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

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
• Y-MABS THERAPEUTICS INC portfolio CI

Frequently asked questions about DANYELZA

Related

• Drug class: All Glycolipid Disialoganglioside-directed Antibody [EPC] drugs
• Target: All drugs targeting GD2
• Manufacturer: Y-MABS THERAPEUTICS INC — full pipeline
• Therapeutic area: All drugs in Neuroscience
• Indication: Drugs for Neuroblastoma

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing