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# Y-mAbs Files BLA for Neuroblastoma
- URL: https://www.fdaweb.com/y-mabs-files-bla-for-neuroblastoma/
- Published: 2020-06-02T12:00:00.000Z
- Updated: 2026-09-14T16:16:45.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5146911

FDA has accepted for review a Y-mAbs Therapeutics BLA for Danyelza (naxitamab) for treating patients with relapsed/refractory high-risk neuroblastoma. The agency has set an 11/30 user fee review action target date, and it has told the company that an advisory committee meeting will not be required. The company describes Danyelza as a humanized monoclonal antibody that targets tumors that express GD2 and B7-H3\. Previously, the agency granted the therapy an orphan drug designation.