Archive

Category: Danyelza

Y-mAbs Reports BLA Submission to the NMPA for Danyelza (naxitamab-gqgk) to Treat Relapsed/Refractory High-Risk Neuroblastoma

Shots: SciClone has submitted the BLA for Danyelza to treat pediatric patients aged >1 yr. and adult patients with r/r high-risk neuroblastoma to NMPA in China If approved, the therapy will be available in the China imminently. The therapy was approved under accelerated approval based on ORR and DoR while the continued approval for the […]

Y-mAbs’ Danyelza (naxitamab-gqgk) Receives the US FDA’s Approval for Neuroblastoma

Shots: The US FDA has approved Danyelza (40mg/10ml) and is indicated in combination with GM-CSF for pediatric patients aged 1yrs. & older and adult patients with r/r high-risk neuroblastoma in the bone marrow The indication is approved under accelerated approval regulation based on ORR and DOR. Continued approval for the indication may be contingent upon […]

Y-mAbs claims FDA OK for neuroblastoma drug Danyelza

Y-mAbs Therapeutics has claimed its first product approval, getting a green light from the FDA for Danyelza for the rare cancer neuroblastoma. Danyelza (naxitamab) is an antibody that targets GD2, a protein found on the surface of some tumour cells, and it has been cleared by the US regulator for use alongside GM-CSF – a […]