Generic Name: naxitamab
Drug Class: Targeted Therapy Medications
Company: Y-mAbs Therapeutics
Approval Status: Approved
Generic Version Available: No
Drug Indication
Danyelza is a monoclonal antibody approved for the treatment of relapsed or refractory high-risk neuroblastoma in the bones or bone marrow that has remained stable or responded to prior therapy.
General Info
Danyelza is a monoclonal antibody that binds to GD2, a protein highly expressed on nervous system cells. Neuroblastoma involves the uncontrolled growth of nervous system cells outside the brain. Binding of the drug to GD2 causes the immune system to attack the cancerous cells. In two studies, Danyelza led to tumor shrinkage in 34% to 45% of patients with neuroblastoma in the bones or bone marrow. Danyelza was first approved in 2020.
Dosage
Dosing Info:
Danyelza is administered as an intravenous infusion on three days in each monthly treatment cycle.
Side Effects
The most common adverse reactions include infusion reactions, rapid heartbeat, nausea, vomiting, diarrhea, decreased appetite, cough, hypertension, fatigue, fever, headache, peripheral neuropathy, hives, swelling and anxiety. Danyelza can cause depletion of red blood cells (anemia), white blood cells (neutropenia) and platelets (thrombocytopenia), which can lead to infections and easy bleeding. More serious side effects may include neurotoxicity and severe hypertension. The product label includes a warning about serious infusion reactions and nerve damage. Danyelza can cause fetal harm if used during pregnancy.
For More Info: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761171lbl.pdf
Last Reviewed: November 27, 2020
