US FDA approves Danyelza® (naxitamab-gqgk) for use in combination with GM-CSF for the treatment of relapsed or refractory high-risk neuroblastoma

Accelerated approval of this orphan drug, a monoclonal antibody that targets the ganglioside GD2, was based on evidence from two studies; further data from one ongoing study (201) is required to verify and further characterise the clinical benefit.

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