Y-mAbs Enters into Exclusive Distribution Agreement with Adium Pharma S.A. for DANYELZA® (naxitamab-gqgk) and Omburtamab in Latin America
DANYELZA (naxitamab-gqgk) 40mg/10mL was approved by the
Omburtamab is an investigational, monoclonal antibody that targets B7-H3 and is radiolabeled before intraventricular administration. B7-H3 is an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. In
The distribution agreement includes the territories of
“We are very pleased to enter this distribution agreement with Adium, a company with a commercial presence in 18 countries and a sustained oncology and rare disease business. We hope to leverage Adium’s footprint in
About DANYELZA® (naxitamab-gqgk)
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 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 for complete Boxed Warning and other important safety information.
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The Company has a broad and advanced product pipeline, including one FDA approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one pivotal-stage product candidate, omburtamab, which targets tumors that express B7-H3.
Adium is a private pharmaceutical company based in
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“DANYELZA” and “Y-mAbs” are registered trademarks of
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Source: Y-mAbs Therapeutics, Inc