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# FDA Grants Y-mAbs Pediatric Disease Designation
- URL: https://www.fdaweb.com/fda-grants-y-mabs-pediatric-disease-designation/
- Published: 2021-10-11T12:00:00.000Z
- Updated: 2026-09-14T17:18:34.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150339

FDA has granted Y-mAbs Therapeutics a rare pediatric disease designation for the company’s lutetium-labeled omburtamab antibody program for treating medulloblastoma. The therapy is currently in a multicenter Phase 1 clinical trial in pediatric patients with refractory medulloblastoma, and in a multicenter Phase 1 clinical trial targeting B7-H3 positive *central nervous system/*leptomeningeal metastases tumors in adults. The designation makes Y-mAbs eligible for a priority review voucher upon potential approval of a BLA for this rare pediatric cancer. The company currently has one FDA approved product, Danyelza (naxitamab-gqgk), which targets tumors that express GD2, and one pivotal-stage product candidate, omburtamab, which targets tumors that express B7-H3.