Naxitamab is under clinical development by Y-mAbs Therapeutics and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Naxitamab’s likelihood of approval (LoA) and phase transition for Osteosarcoma took place on 12 Jan 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Naxitamab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Naxitamab overview

Naxitamab (Danyelza) is a monoclonal antibody, acts as anti-cancer agent. It is formulated as injection solution for intravenous route of administration. Danyelza is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GMCSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. It is also under development for the treatment of soft-tissue Sarcomas, triple negative breast cancer, Melanoma. Naxitamab is under investigation for the treatment of osteosarcoma. It is administered as intravenous infusion. It is a human IgG3 MAb. The drug candidate acts by targeting ganglioside GD2.

Y-mAbs Therapeutics overview

Y-mAbs Therapeutics(Y-mAbs) is a clinical biopharmaceutical company. It develops and commercializes novel antibody therapeutic products for cancer treatment. The Company technologies include bispecific antibodies generated using the Y-BiClone platform and the SADA platform. The Company product pipeline includes DANYELZA (naxitamab-gqgk), which targets tumors that express GD2, and omburtamab, which targets tumors that express B7-H3. DANYELZA is a humanized monoclonal antibody in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of in the bone or bone marrow stable disease to prior therapy and being evaluated for the treatment of other GD2-positive tumors. It also develops Omburtamab, which is novel murine monoclonal antibody targeting B7-H3. The Company is conducting Phase II clinical trials for the treatment of patients with first-line NB, third-line NB, and in relapsed osteosarcoma. It has a license and research collaboration agreement with Memorial Sloan-Kettering Cancer Center. Y-mAbs is headquartered in New York City, New York, the US.

Quick View Naxitamab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Naxitamab
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.