Y-mAbs Announces Update to National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for Neuroblastoma to Include Naxitamab-gqgk (DANYELZA®)

Core Viewpoint - Y-mAbs Therapeutics, Inc. announced that naxitamab-gqgk (DANYELZA®) has been recommended as a Category 2A treatment option for high-risk neuroblastoma by the National Comprehensive Cancer Network (NCCN) [1][2] Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company focused on developing and commercializing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [8] - The company’s product pipeline includes DANYELZA (naxitamab-gqgk), which is the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma in patients who have shown a partial response, minor response, or stable disease to prior therapy [8] Product Information - Naxitamab-gqgk (DANYELZA) was granted accelerated approval by the FDA on November 25, 2020, for pediatric patients aged one year and older and adult patients with relapsed or refractory high-risk neuroblastoma [3] - The approval was based on efficacy results from two single-arm, open-label trials [3] - DANYELZA is indicated for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) [6] - The product includes a Boxed Warning for serious infusion-related reactions and neurotoxicity [6] NCCN Guidelines - The NCCN is a not-for-profit alliance of 33 leading cancer centers focused on advancing quality cancer care [4] - The inclusion of DANYELZA in the NCCN Guidelines reinforces its position as a leading anti-GD2 therapy for high-risk neuroblastoma [2]