Naxitamab

Naxitamab, sold under the brand name Danyelza, is an anti-cancer medication. It is a monoclonal antibody used in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for people one year of age and older with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow demonstrating a partial response, minor response, or stable disease to prior therapy.

The most common adverse reactions include injection site reactions or infusion-related reactions, pain, tachycardia (fast heart beats), vomiting, cough, nausea, diarrhea, decreased appetite, hypertension, fatigue, erythema multiforme, peripheral neuropathy, urticaria, pyrexia, headache, injection site reaction, edema, anxiety, localized edema, and irritability.

The U.S. Food and Drug Administration (FDA) granted the application for naxitamab priority review, breakthrough therapy, and, orphan drug designations. The FDA issued a priority review voucher for this rare pediatric disease product application and was later granted a priority approval.