Skip to main content

Danyelza FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

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

Nov 27, 2020Approval FDA 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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.