Naxitamab-gqgk

(Danyelza®)

Danyelza®

Drug updated on 5/17/2024

Dosage FormInjection (intravenous; 40 mg/10 mL [4 mg/mL])
Drug ClassGD2-binding monoclonal antibodies
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated, in combination with granulocyte-macrophage colony-stimulating factor (GMCSF), 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.

Summary
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  • Naxitamab-gqgk (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.
  • Three randomized controlled trials were reviewed. One study specifically examined Danyelza's safety and efficacy, while another focused on GD2/GD3 vaccine as an alternative treatment approach for high-risk neuroblastoma. The third document discussed statins but was not directly comparable as it pertained to a different cancer context.
  • In terms of safety profile comparison between Danyelza and GD2/GD3 vaccine, at least 50% of patients experienced various adverse events like pain, hypotension, bronchospasm, etc., when treated with Danyelza. However, these adverse effects were generally manageable through premedications and supportive therapies, whereas the GD2/GD3 vaccine had self-limited injection-associated local reactions without any > grade 3 toxicities reported.
  • Direct comparison of efficacy between Danyelza and other treatments within these studies is challenging due to a lack of detailed outcome data for naxitamab-gqgk; however, the continuation of its clinical trial suggests promising results compared to the clear survival benefits presented by the GD2/GD3 Vaccine study, which showed a progression-free survival rate at five years being around 32% ±6%, indicating significant impact on patient outcomes.
  • Management protocols are emphasized, particularly regarding early recognition and management of infusion-related AEs during the administration of naxitamab-gqgk. Highlighting the importance of outpatient care adjustments, education of both patients and caregivers is essential for ensuring better handling of potential side-effects, thereby improving the overall effectiveness of the drug regimen.
  • The relevance of the second document discussing statins is indirect at best, underscoring the contextual limitations of cross-study comparisons in this specific inquiry.

Product Monograph / Prescribing Information

Document TitleYearSource
Danyelza (naxitamab-gqgk) Prescribing Information.2024Y-mAbs Therapeutics, Inc., New York, NY

Randomized Controlled Trials