FDA approves Danyelza for bone or bone marrow recurrence or recurring neuroblastoma

Y-mAbs Therapeutics recently announced that the FDA has approved the GD2 monoclonal antibody Danyelza (naxitamab-gqgk) for the treatment of certain patients with neuroblastoma.
danyelza can be used in combination with granulocyte macrophage collection stimulation factors (GM-CSF) in adult and child patients with bone or bone marrow recurrence or refrmmune high-risk neuroblastoma.
decision was based on data from ongoing trials of 201 and 12-230, in which 95 patients were included in the group, while the 12-230 study is expected to recruit about 224 participants.
201 study, patients received a Danyelza combined intraskinal injection of GM-CSF through intravenous infusions on the first, third and fifth days of each four-week.
the main therapeutic endpoints are total remission rate (ORR) and remission duration (DOR).
45 percent of the 22 patients treated in the study 201, 30 percent had DOR for six months or more, according to the FDA.
, ORR was 34 percent of the 38 patients treated in the 12-230 study, while 23 percent had DOR greater than or equal to six months.
the agency noted that in both trials, reactions were observed in bones, bone marrow or both.
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