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DANYELZA® (naxitamab-gqgk) 40mg/10mL Injection and Indicated Disease State

DANYELZA® (naxitamab-gqgk) 40mg/10mL Injection and Indicated Disease State
March 27, 2021 root
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DANYELZA® and Indicated Disease State

The purpose of this module is first to provide an introduction to neuroblastoma, the treatment for high-risk neuroblastoma, and targeting GD2 in neuroblastoma. Secondly, it will familiarize you with the mechanism of action of DANYELZA® and the results from the key clinical trials that led to the conditional FDA approval of DANYELZA®. Lastly, it will highlight the most common adverse reactions associated with DANYELZA® administration.

Please see Important Safety Information including Boxed Warning on serious infusion-related reactions and neurotoxicity.

DANYELZA® and Y-mAbs® are registered trademarks of Y-mAbs Therapeutic, Inc.

Course Content

DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).