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Y-mabs’ Danyelza for R/R High-Risk Neuroblastoma: Business & Launch Strategies

Danyelza High risk Neuroblastoma Launch Strategy

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:

Ymab DANYELZA Launch Strategy in High-risk neuroblastoma

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.

Sponsor/CollaboratorClinical PhaseDrug
Jubilant DraxImage Inc.Phase 2131I-MIBG
United TherapeuticsPhase 2Unituxin in combination with irinotecan and temozolomide
Clarity Pharmaceuticals LtdPhase 267Cu-SARTATE
Molecular Insight Pharmaceuticals, Inc.Phase 2Ultratrace Iobenguane

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