publication date: Dec. 4, 2020
Drugs & Targets
Danyelza receives FDA approval for treatment of neuroblastoma
FDA has granted accelerated approval to Danyelza (naxitamab-gqgk) 40mg/10ml in combination with granulocyte-macrophage colony-stimulating factor for the treatment of pediatric patients one 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.
Danyelza is sponsored by Y-mAbs Therapeutics Inc.
This indication is approved under accelerated approval regulation based on overall response rate and duration of response.
Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial.
Danyelza is a humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas. Danyelza is administered to patients three times in a week in an outpatient setting and the treatment is repeated every four weeks. The product has received Priority Review, Orphan Drug, Breakthrough Therapy, and Rare Pediatric Disease designations from FDA.
The FDA approval of Danyelza is supported by clinical evidence from two pivotal studies in patients with high-risk neuroblastoma with refractory or relapsed disease. Danyelza appears to be well tolerated with few discontinuations of treatment in the clinical trials and adverse events were clinically manageable.
The postmarketing clinical trial required by the FDA to verify and to further characterize the clinical benefit is the ongoing Study 201, which will enroll a minimum of 80 patients and report overall response rate, duration of response, progression free survival and overall survival. The ORR is the primary endpoint for the study, DOR is the secondary endpoint, … Continue reading Danyelza receives FDA approval for treatment of neuroblastoma
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