Naxitamab is under clinical development by Y-mAbs Therapeutics and currently in Phase II for Ewing Sarcoma. According to GlobalData, Phase II drugs for Ewing Sarcoma does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Naxitamab LoA Report. Buy the report here.

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Data Insights Likelihood of Approval and Phase Transition Success Rate Model - Naxitamab in Ewing Sarcoma

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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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 ewing sarcoma, metastatic melanoma, 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.

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Y-mAbs Therapeutics overview

Y-mAbs Therapeutics(Y-mAbs) is a clinical biopharmaceutical company that 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. Its pipeline products include DANYELZA (naxitamab-gqgk) treats relapsed and refractory high-risk neuroblastoma, front-line induction in high-risk neuroblastoma, relapsed second-line osteosarcoma, chemoimmunotherapy for relapsed and refractory high-risk neuroblastoma; GD2-SADA for solid tumors (SCLC, malignant melanoma, sarcoma);

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.