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Danyelza FDA Approval History

FDA Approved: Yes (First approved November 25, 2020)
Brand name: Danyelza
Generic name: naxitamab-gqgk
Dosage form: Injection
Company: Y-mAbs Therapeutics, Inc.
Treatment for: Neuroblastoma

Danyelza (naxitamab-gqgk) is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GMCSF), for the treatment of patients with relapsed or refractory high-risk neuroblastoma.

Development Timeline for Danyelza

DateArticle
Nov 27, 2020ApprovalFDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma
Apr  1, 2020Y-mAbs Announces Submission of Naxitamab Biologics License Application to U.S. FDA
Jul  8, 2019Y-mAbs Announces Successful Pre-BLA Meeting with FDA for Naxitamab

Further information

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