- DANYELZA (naxitamab-gqgk) gains Category 2A status in NCCN Guidelines.
- Validated as a treatment for relapsed/refractory high-risk neuroblastoma.
- FDA accelerated approval reinforces its leading position in anti-GD2 therapies.
The National Comprehensive Cancer Network® (NCCN®) has included Y-mAbs Therapeutics' (YMAB, Financial) drug naxitamab-gqgk, marketed as DANYELZA®, in its Clinical Practice Guidelines in Oncology as a Category 2A treatment option for high-risk neuroblastoma. This inclusion is a critical acknowledgment of DANYELZA's clinical significance in treating relapsed or refractory high-risk neuroblastoma, especially in pediatric patients aged one year and older, as well as in adults.
DANYELZA, which received accelerated approval from the U.S. Food and Drug Administration (FDA) in November 2020, is administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF). Its FDA approval was based on positive efficacy results from two significant trials, Study 201 and Study 12-230, conducted on patients showing partial response or at least stable disease after prior therapies.
This development is a major milestone for Y-mAbs Therapeutics as NCCN Guidelines are a vital resource for oncologists in treatment planning. NCCN's recommendation will likely facilitate DANYELZA's integration into clinical practices across leading cancer centers, potentially bolstering its adoption and market penetration. Additionally, the NCCN endorsement can significantly influence reimbursement decisions by health insurers, supporting broader patient access and enhancing Y-mAbs' commercial prospects.
