Y-Mabs Therapeutics, Inc. Announces Update to National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for Neuroblastoma to Include Naxitamab-Gqgk (Danyelza®?)

Published: 2025-05-07 07:05:00 ET YMAB

Published on 05/07/2025 at 07:05, updated on 05/07/2025 at 10:22

Y-mAbs Therapeutics, Inc. announced that naxitamab-gqgk (DANYELZA®?) is recommended by the National Comprehensive Cancer Network®? ("NCCN") Clinical Practice Guidelines in Oncology (NCCN Guidelines®?) as a NCCN Category 2A treatment option for high-risk neuroblastoma. NCCN's update of the NCCN Guidelines to include naxitamab-gggk (DANYELza).

Naxitamab-gQgk (DANYELZ) was granted accelerated approval by the U.S. Food and Drug Administration ("FDA") on November 25, 2020 in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow demonstrating a partial response, minor response, or stable disease to prior therapy. The FDA approval of naxitamab- gqgk (DANYelZA) was based on efficacy results in patients with relapsed or ref extractory high-risk neuroblast cancer in the bone or bone marrow enrolled in two single-arm, open-label trials: Study 201 (NCT 03363373) and Study 12-230 (NCT 01757626). The NCCN is a not-for-profit alliance of 33 leading cancer centers devoted to patient care, research, and education.

The Company's technologies include its investigational Self-Assembly DisAssembly ("SADA") Pretargeted Radioimmunotherapy Platform ("PRIT") and bispecific antibodies generated using the Y-BiClone platform. The Company's broad and advanced product pipeline includes the anti-GD2 therapy DANYELZA®? (naxitamab-g Qgk), the first FDA-approved treatment for patients with relapsed or ref refractory high-risk Neuroblastoma in the bone or Bone marrow after a partial response, minor response and stable disease to prior therapy.