SERB Pharmaceuticals announced the successful completion of its acquisition of Y-mAbs Therapeutics, a commercial-stage biopharmaceutical company focused on the development and commercialization of antibody-based therapeutics for the treatment of cancer.
“We are excited to welcome Y-mAbs into SERB. The acquisition strengthens our Rare Oncology portfolio with the addition of Danyelza® (naxitamab-gqgk) and brings deep oncology expertise that will help us to expand our partnerships with the US oncology community and to advance treatments for rare and hard-to-treat cancers”, said Vanessa Wolfeler, Chief Executive Officer of SERB. “This marks a significant step forward in delivering on SERB’s growth strategy and vision, but more importantly, it allows us to help more children and families facing pediatric cancers.”
Danyelza® (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), 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. 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.
Danyelza® is currently not approved for the treatment of osteosarcoma in any jurisdiction.
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