DANYELZA

NAXITAMAB

Manufacturer: Y-mAbs Therapeutics, Inc.

Score: 141.0

Quick Summary

DANYELZA is a glycolipid disialoganglioside (GD2)-binding recombinant humanized monoclonal IgG1 antibody used 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. The recommended dosage is 3 mg/kg/day administered as an intravenous infusion after dilution on Days 1, 3, and 5 of each treatment cycle, with treatment cycles repeated every 4 weeks until complete response or partial response, followed by 5 additional cycles every 4 weeks. DANYELZA can cause serious infusion reactions and severe neurotoxicity, and it is contraindicated in patients with a history of severe hypersensitivity reaction to naxitamab-gqgk.

Key Clinical Findings and Indications

Treatment of relapsed or refractory high-risk neuroblastoma in the bone or bone marrow
Used in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF)
Approved under accelerated approval based on overall response rate and duration of response

Important Safety Information

Warning

Serious infusion-related reactions and neurotoxicity, including severe neuropathic pain, transverse myelitis, and reversible posterior leukoencephalopathy syndrome (RPLS)

Contraindications

History of severe hypersensitivity reaction to naxitamab-gqgk

Adverse Reactions

Infusion-related reactions
Pain
Tachycardia
Vomiting
Cough
Nausea
Diarrhea
Decreased appetite
Hypertension
Fatigue
Erythema multiforme
Peripheral neuropathy
Urticaria
Pyrexia
Headache
Injection site reaction
Edema
Anxiety
Localized edema
Irritability

Dosing Recommendations

General Guidance

Dosage modifications for adverse reactions are presented in Table 2 of the prescribing information

Relapsed or refractory high-risk neuroblastoma

Adult Dose

3 mg/kg/day (up to 150 mg/day) administered as an intravenous infusion after dilution on Days 1, 3, and 5 of each treatment cycle

Pediatric Dose

3 mg/kg/day (up to 150 mg/day) administered as an intravenous infusion after dilution on Days 1, 3, and 5 of each treatment cycle for patients 1 year of age and older

Special Population Considerations

Pregnancy

Based on its mechanism of action, DANYELZA may cause fetal harm when administered to pregnant women
No available data on the use of DANYELZA in pregnant women

Nursing Mothers

Pediatric Use

Safety and effectiveness established in pediatric patients 1 year of age and older
Safety and effectiveness have not been established in pediatric patients younger than 1 year of age

Geriatric Use

Neuroblastoma is largely a disease of pediatric and young adult patients
Clinical studies of DANYELZA in combination with GM-CSF did not include patients 65 years of age and older