U.S. Food and Drug Administration has approved naxitamab-gqgk 40mg/10ml. It is indicated in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”) for pediatric patients of one year or above that and adult patient’s treatment who were suffering from relapsed high-risk neuroblastoma in the bone marrow or bone that have shown a incomplete response or stable disorder to previous treatment.
Constant approval for this indication may be dependent on the verification and depiction of clinical benefits in an affirmative trial.
Naxitamab-gqgk is a monoclonal antibody which targets the ganglioside GD2. Ganglioside GD2 is highly expressed in different neuroectoderm-derived sarcomas and tumors.
Naxitamab-gqgk is given to the patients thrice a week, and the treatment is repeated every four weeks.
The FDA approval of naxitamab-gqgk is aided by clinical verification from two pivotal studies in patients suffering from high-risk refractory neuroblastoma. Naxitamab-gqgk found to be well tolerated with hardly any treatment discontinuations in the clinical trials. There were clinically manageable adverse events.
To further illustrate the clinical benefit, the postmarketing clinical trial needed by the FDA is the ongoing Study 201. It will include at least eighty patients. It will describe the overall survival (OS), overall response rate (ORR), duration of response (DOR) and progression free survival (PFS).
The primary result of the study is OS. The secondary result is DOR. PFS and OS are secondary results during durable follow up.
Naxitamab-gqgk is contraindicated in patients having a record of severe hypersensitivity response to naxitamab-gqgk. Anaphylaxis is among the reactions.
|Link to the source:||https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761171lbl.pdf
[Last accessed on: 1 December, 2020]
|Original title of article:||FDA Approves Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the Treatment of Neuroblastoma|
Disease area: Neuroblastoma
Tags: Therapeutic, Naxitamab, Neuroblastoma, Chronic, Targeted Therapy Medications, Efficacy, Safety