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# Y-mAbs Therapeutics Gets Orphan/Rare Pediatric Status
- URL: https://www.fdaweb.com/y-mabs-therapeutics-gets-orphan-rare-pediatric-status/
- Published: 2020-10-08T12:00:00.000Z
- Updated: 2026-09-14T16:31:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147836

FDA has granted Y-mAbs Therapeutics an orphan drug designation and rare pediatric disease designation for its antibody nivatrotamab and its use in treating neuroblastoma. The humanized bispecific 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 GD2(+) solid tumors, where patients have relapsed or refractanory disease that is resistant to standard therapy, according to the company.