The Y-mabs’ antibody candidate naxitamab-gqgk (Danyelza) for the treatment of high-risk neuroblastoma was recently approved by the FDA. This approval is subject to naxitamab-gqgk (Danyelza) for the treatment of pediatric patients aged 1 year and older. The decision is supported by 2 clinical studies which demonstrated a partial response, minor response or stable disease to previous therapy.
In 2019, a pre-BLA meeting held with the FDA for Ymab’s Danyelza. This meeting had already provided insights into this great novelty for the treatment of neuroblastoma. After 1 year, the company immediately submitted the BLA application to the US FDA which led to the approval of naxitamab-gqgk in the US.
The first licensing application for biologics represents Y-mAbs’ success in the area of antibody-based oncology products that meet pediatric and adult medical needs. Danyelza’s second-line label is broader than that of United Therapeutics incumbent Unituxin, including adults as well as pediatric patients, and the new drug is dosed via a 30-minute infusion, rather than 10 to 20 hours. On the other hand, this product also received a priority review, orphan drug, breakthrough therapy, and rare pediatric disease designation by the FDA.
Key Mellalta Meets Findings:
About Ymab’s Danyelza
Naxitamab-gqgk (Danyelza) is a humanized anti-GD2 lgG1k antibody was developed by the Memorial Sloan Kettering Cancer Center. In the first phase of development, Y-mAbs Therapeutics licensed this antibody for further clinical studies. It was originally designed to target GD2 ganglioside, which is expressed in various neuroectodermal-derived tumors and sarcomas.
Y-mAbs’ Chief Executive Officer Claus Moller said: “We believe that danyelza in combination with GM-CSF is a much-needed treatment for patients with relapsed/refractory high-risk neuroblastoma in the bone or bone marrow who have historically not had approved treatments available.
“This approval of Y-mAbs’ first BLA represents a key step in working towards our mission of becoming a world leader in developing better and safer antibody-based oncology products addressing unmet pediatric and adult medical needs.”
Competition in High Risk Neuroblastoma
In addition to the Y-mAbs, there are 20+ clinical trials, which are directly emerging their drug in the battle of the unmet needs of neuroblastoma patients.
United Therapeutics: Based on the results of the ANBL1221 study conducted by the Children’s Oncology Group, the company is also performing a label expansion for Unituxin in combination with irinotecan and temozolomide for the treatment of pediatric patients with relapsed or refractory neuroblastoma.
|Jubilant DraxImage Inc.||Phase 2||131I-MIBG|
|United Therapeutics||Phase 2||Unituxin in combination with irinotecan and temozolomide|
|Clarity Pharmaceuticals Ltd||Phase 2||67Cu-SARTATE|
|Molecular Insight Pharmaceuticals, Inc.||Phase 2||Ultratrace Iobenguane|