NEW YORK, May 23, 2023 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (“Anvisa”) has granted marketing authorization for DANYELZA (naxitamab-gqgk) 40mg/10mL injection. DANYELZA will be marketed in Brazil by Y-mAbs’ partner Adium Pharma S.A. (“Adium”).
DANYELZA is a recombinant 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 and the treatment is repeated every four weeks.
“Today is an important day for children living with refractory/relapsed high-risk neuroblastoma in Brazil. It’s very exciting to see this treatment approved, creating access to DANYELZA in Brazil from the joint efforts by our partner Adium and the development team at Y-mAbs. We continue to focus on expansion of DANYELZA in other jurisdictions, working to provide access to children living with refractory or relapsed neuroblastoma,” said Thomas Gad, founder, President and Interim CEO.
Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests related to the compound and Y-mAbs.
About DANYELZA® (naxitamab-gqgk)
In the United States, DANYELZA® (naxitamab-gqgk) 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 was approved by the US Food and Drug Administration (“FDA”) 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 benefits in a confirmatory trial. DANYELZA® includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information (https://labeling.ymabs.com/danyelza) for complete Boxed Warning and other important safety information.