The Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (Anvisa) has granted marketing authorization for Y-mAbs Therapeutics’ DANYELZA (naxitamab-gqgk) 40mg/10mL injection. DANYELZA will be marketed in Brazil by Y-mAbs’ partner Adium Pharma.
DANYELZA is a recombinant humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas. DANYELZA is administered to patients three times in a week and the treatment is repeated every four weeks.
“Today is an important day for children living with refractory/relapsed high-risk neuroblastoma in Brazil. 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 expansion of DANYELZA in other jurisdictions, working to provide access to children living with refractory or relapsed neuroblastoma,” said Thomas Gad, founder, president and interim CEO.
Researchers at Memorial Sloan Kettering Cancer Center (MSK) developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests related to the compound and Y-mAbs.