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Treatment or breakthrough of neuroblastoma: Nivatrotamab receives FDA "Orphan Drug Title" and "Rare Paediatric Disease Title"

 Last Update: 2020-10-10
 Source: Internet
 Author: User

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Neuroblastoma is a form of cancer that forms in specific nerve tissues.
most often starts with one side of the adrenal gland, but can also develop in the neck, chest, abdomen or spinal cord.
symptoms include bone pain, lumps in the abdomen, neck or chest, or painless blue lumps under the skin.
biopharmaceutical company Y-mAbs Therapeutics announced today that the FDA has awarded its leading dual-specific antibody nivatrotamab the title of orphan drug (ODD) and the title of rare pediatric disease (RPDD) for the treatment of neuroblastoma.
Nivatrotamab is an humanized biscometic anti-GD2 antibody and is currently working with the Memorial Sloan Kettering Cancer Center to conduct Phase I clinical trials to treat recurring GD2-positive neuroblastoma and advanced osteosarcoma.
Thomas Gad, president of Y-mAbs Therapeutics, said: "We are very pleased with nivatrotamab's ODD, as this could give us seven years of market exclusive access after going public.
RPDD makes us eligible for a Priority Review Certificate (PRV) upon approval of a Biopharmaceity License application."
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