Y-mAbs Therapeutics has received marketing authorisation for Danyelza (naxitamab-gqgk) 40mg/10mL injection from the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária, to treat high-risk neuroblastoma.
Danyelza is a recombinant humanised monoclonal antibody that acts on the ganglioside GD2 that is highly expressed in several neuroectoderm-derived tumours and sarcomas.
It was developed by researchers at the Memorial Sloan Kettering Cancer Center in New York and is exclusively licensed to Y-mAbs.
The therapy is given three times a week and repeated every four weeks.
South American pharmaceutical company Adium Pharma, a partner of Y-mAbs, will be responsible for marketing Danyelza in Brazil.
Y-mAbs founder, president and interim CEO Thomas Gad stated: “Today is an important day for children living with refractory/relapsed high-risk neuroblastoma in Brazil.
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“It’s very exciting to see this treatment approved, creating access to Danyelza in Brazil from the joint efforts by our partner Adium and the development team at Y-mAbs.
“We continue to focus on the expansion of Danyelza in other jurisdictions, working to provide access to children living with refractory or relapsed neuroblastoma.”
The combination of Danyelza and granulocyte-macrophage colony-stimulating factor (GM-CSF) also received approval from the US Food and Drug Administration.
It is indicated to treat relapsed or refractory high-risk neuroblastoma in the bone or bone marrow of paediatric patients aged one year and above, and of adult patients, who have shown a partial or minor response to previous treatment or have stable disease.
The therapy was cleared under accelerated approval guidelines based on the duration of response and overall response rate.