Naxitamab is under clinical development by Y-mAbs Therapeutics and currently in Phase II for Osteosarcoma. According to GlobalData, Phase II drugs for Osteosarcoma have a 13% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Naxitamab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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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 soft-tissue Sarcomas, 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.

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 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 a 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 relapsed osteosarcoma. It has a license and research collaboration agreement with Memorial Sloan-Kettering Cancer Center. Y-mAbs is headquartered in New York, the US.

For a complete picture of Naxitamab’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 7 February 2024

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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 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.