for intravenous use Initial U.S. Approval: 2020
Danyelza (naxitamab-gqgk) is a medication used to treat children aged 1 year or older and adults with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow.
Facts about naxitamab-gqgk injection
Dosage Forms and Strengths: Injection: 40 mg/10 mL (4 mg/mL) in a single-dose vial.
MEDICINE APPROVED BY-Food and Drug Administration (FDA)
Summary of FDA-approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
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Query For naxitamab-gqgk injection
Approved accessible "naxitamab-gqgk injection"
Naxitamab is used in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) to treat people one year of age and older with high-risk neuroblastoma in bone or bone marrow whose tumor did not respond to or has come back after previous treatments and has shown a partial response, minor response, or stable disease to prior therapy.
Naxitamab, 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 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.
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Danyelza (naxitamab-gqgk injection) for intravenous use Initial U.S. Approval: 2020
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