FDA Grants Accelerated Approval to Danyelza to Treat Neuroblastoma

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The FDA has approved naxitamab-gqgk in combination with GM-CSF for children with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow. Naxitamab is a monoclonal antibody that targets ganglioside GD2, commonly found in neuroectoderm-derived tumors. This approval is granted for patients aged 1 year and older who have shown a response or stable disease after previous treatment. accelerators. This approval provides a new treatment option for a specific population of pediatric patients with neuroblastoma.

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