Posted by Michael Wonder on 08 Oct 2020
Y-mAbs’ nivatrotamab for the treatment of patients with neuroblastoma granted orphan drug designation and rare paediatric disease designation by FDA
7 October 2020 - Y-mAbs Therapeutics today announced that the FDA has granted orphan drug designation and rare paediatric disease designation for its leading bi-specific antibody program nivatrotamab for the treatment of neuroblastoma.
Nivatrotamab, a humanised bi-specific anti-GD2 antibody, is currently in Phase 1 clinical development in collaboration with Memorial Sloan Kettering Cancer Center in patients with relapsed/refractory neuroblastoma, as well as high grade osteosarcoma and other solid tumours, where patients have relapsed or refractory disease that is resistant to standard therapy.
